Radiopharmaceuticals in Precision Medicine: What's Changing

Between May and September 2022, the average wait time for an eligible patient to start on lutetium Lu 177 vipivotide tetraxetan (Pluvicto) at Dana-Farber Cancer Institute was eight weeks ^[18]. The drug had extended median overall survival by four months in men with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in the pivotal VISION trial ^[1], and demand immediately exceeded what a single approved European manufacturing facility could supply ^[18]. By early 2023, the situation had deteriorated further: Novartis halted new patient starts entirely and reserved available doses for those already in treatment, projecting that the FDA review of its Millburn, New Jersey facility would take four to six months ^[22].

That sequence illustrates the defining tension in radiopharmaceutical therapy (RPT) as a clinical development modality: the science has produced compelling evidence, the investment following it is substantial, and the infrastructure to deliver these therapies reliably at scale is still catching up. For sponsors running radiopharmaceutical clinical trials, the gap between therapeutic promise and operational reality shapes almost every major planning decision.

Why This Topic Matters in Clinical Trials

Radiopharmaceuticals are not a new class of medicines. Iodine-131 for thyroid conditions has been in clinical use for decades, and radium-223 dichloride (Xofigo) received FDA approval in 2013 for symptomatic bone metastases in mCRPC ^[3]. What changed in the years following the NETTER-1 trial and the VISION trial was the convergence of three developments: proof that molecularly targeted radiopharmaceuticals could improve clinically meaningful outcomes in difficult-to-treat cancers, advances in companion diagnostic imaging (particularly PSMA-PET and somatostatin receptor PET), and a wave of pharma investment that transformed RPT from a subspecialty of nuclear medicine into an increasingly prominent oncology modality.

The numbers reflect how fast that shift has occurred. Industry-sponsored RPT clinical trials grew 64% between 2019 and 2023, and academic studies in the same space increased 72% over the same period, according to Parexel's analysis of the clinical trial registry ^[4]. A separate analysis found that the number of clinical trials evaluating radiopharmaceuticals grew 37% between 2020 and 2024 ^[5]. As of July 2025, more than 400 clinical trials are registered exploring novel radiopharmaceutical targets including fibroblast activation protein (FAP), carbonic anhydrase IX (CAIX), and gastrin-releasing peptide receptor (GRPR), alongside alternative radionuclides and combination regimens in both solid and hematologic malignancies ^[6].

The financial dimension reinforces this trajectory. Venture financing of RPT companies more than quintupled in the five years ending in 2023 ^[4]. Novartis's two approved agents, Lutathera and Pluvicto, together generated $2.8 billion in revenue in 2025 ^[7]. Between October 2023 and June 2024, three major pharmaceutical companies entered the RPT space through acquisition: Eli Lilly acquired POINT Biopharma for approximately $1.4 billion in October 2023 ^[20], Bristol Myers Squibb completed its acquisition of RayzeBio for approximately $4.1 billion in February 2024 ^[19], and AstraZeneca closed its acquisition of Fusion Pharmaceuticals for approximately $2.4 billion in June 2024 ^[8]. Each acquired pipeline included actinium-225-based programs: POINT's LY4181530 (formerly PNT2001, 225Ac-PSMA-62), which entered the Phase Ia/Ib ACCEL trial (NCT06229366) in prostate cancer ^[26]; RayzeBio's RYZ101 (225Ac-DOTATATE, Phase 3 in GEP-NETs) ^[19]; and Fusion's FPI-2265 (225Ac-PSMA, Phase 2 in mCRPC) ^[8].

For clinical research teams, this pace of development has direct consequences: protocol complexity is increasing, site qualification criteria are more specialized than in standard oncology trials, and supply chain constraints can interrupt or pause studies mid-enrollment.

Current Evidence and the Research Pipeline

The Approved Foundation

Two pivotal Phase III trials established the clinical case for modern targeted radiopharmaceuticals.

The NETTER-1 trial (NCT01578239) enrolled 229 patients with progressive, well-differentiated, locally advanced or metastatic somatostatin receptor-positive midgut carcinoid tumors. Participants received either lutetium Lu 177 dotatate (Lutathera) combined with long-acting octreotide, or high-dose octreotide alone. The trial demonstrated a significant improvement in progression-free survival favoring the radiopharmaceutical arm, and the FDA approved lutetium Lu 177 dotatate on January 26, 2018, as the first radiopharmaceutical approved for this indication ^[9].

The VISION trial (NCT03511664) followed a different eligibility model: patients with mCRPC were required to have PSMA-positive gallium-68-labeled PSMA-11 PET/CT scans before enrollment, directly embedding a companion diagnostic requirement into the protocol. Among 831 randomized patients who had received at least one androgen receptor pathway inhibitor and one or two prior taxane regimens, 177Lu-PSMA-617 plus best standard of care produced a median overall survival of 15.3 months, compared with 11.3 months in the standard-of-care-alone arm (hazard ratio 0.62; 95% CI 0.52 to 0.74; P < 0.001). Imaging-based progression-free survival favored the experimental arm with a hazard ratio of 0.40 (99.2% CI, 0.29 to 0.57; P < 0.001) ^[1]. The FDA granted traditional approval on March 23, 2022, based on those results ^[2].

The Pluvicto indication has since expanded. On March 28, 2025, the FDA approved Pluvicto for an earlier patient population: adults with PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy ^[21]. That expanded indication was based on the Phase III PSMAfore trial (NCT04689828), in which Pluvicto reduced the risk of radiographic progression or death by 59% compared with a change in ARPI therapy (HR=0.41; 95% CI: 0.29, 0.56; P < 0.0001) ^[21]. Novartis estimated the expanded label approximately triples the number of patients eligible to receive Pluvicto ^[23].

What Lutetium-177 Has Demonstrated

Lutetium-177 (177Lu) has emerged as the dominant isotope in therapeutic radiopharmaceuticals, and its properties explain why. Its half-life of 6.7 days allows for centralized manufacturing and shipping to clinical sites, its beta emissions travel roughly 2 millimeters in tissue, and it also emits gamma radiation that permits post-treatment imaging to verify biodistribution. A 2025 review in Frontiers in Medicine identified more than 200 clinical studies currently underway using lutetium-177, making it the current reference isotope for RPT ^[10].

Lutathera and Pluvicto both use the same isotope but pair it with distinct targeting molecules. DOTATATE, a somatostatin analogue, binds to somatostatin type 2 receptors overexpressed on neuroendocrine tumor cells. PSMA-617 targets prostate-specific membrane antigen on prostate cancer cell surfaces. Critically, the diagnostic imaging agents used in each program (gallium-68 DOTATATE and gallium-68 PSMA-11, respectively) are separate ligands that target the same receptor as their therapeutic counterparts but are not identical molecules. The targeting approach is the same; the specific ligand structures differ. This distinction matters for companion diagnostic labeling, regulatory filing strategy, and what is claimed in the Investigator Brochure.

The Alpha Emitter Wave

While lutetium-177 defines the current generation of approved therapies, a substantial portion of the late-stage pipeline has shifted toward alpha-emitting isotopes, particularly actinium-225 (225Ac). Alpha particles deliver a much higher linear energy transfer per unit distance traveled than beta emitters, potentially producing greater cytotoxic effects per targeted cell while limiting radiation scatter to surrounding tissue. The three large-pharma acquisitions described above, totaling approximately $7.9 billion across all three transactions, each brought actinium-225-based programs into major commercial pipelines.

The clinical excitement around actinium-225 has run ahead of production infrastructure. Bristol Myers Squibb's RayzeBio was forced to pause a Phase III trial in 2024 due to an actinium-225 shortage, a supply chain disruption that underscored how dependent radiopharmaceutical development is on reactor capacity and isotope processing capabilities that are still concentrated in a small number of global facilities ^[7]. Actinium-225 has been supplied primarily by Oak Ridge National Laboratory for nearly three decades, and simultaneous surges in late-stage clinical demand from multiple programs have strained that supply base ^[7].

Operational and Trial Design Considerations

Running a radiopharmaceutical trial requires operational infrastructure that most standard oncology sites do not have, and the differences begin before a single patient is screened.

Site Qualification Is a Specialized Process

Most RPT protocols require sites to have nuclear medicine departments with gamma camera or PET/CT capabilities, radiation safety officers, designated hot labs for handling radiopharmaceuticals, and staff trained in radiation protection and radioactive materials handling. Investigative sites that are otherwise excellent oncology centers may lack one or more of these requirements. Identifying sites that hold this intersection of nuclear medicine, oncology, and radiation safety capabilities requires feasibility intelligence beyond what standard site databases typically provide; Kitsa's KScout site selection tool is designed to surface this kind of layered site profile. According to site experts, the availability of gamma cameras at some academic centers is already constrained by routine clinical imaging load, and adding dosimetry imaging for a clinical trial can meaningfully reduce availability for standard-of-care patients ^[11].

Site qualification requirements also vary significantly by jurisdiction. In Spain, Good Manufacturing Practice facility requirements have excluded some established academic centers from participating in theranostic trials despite their clinical expertise in oncology ^[11]. The regulatory framework governing radioactive materials transport, storage, and administration differs across the EU, the United States, and other regions, meaning site authorization processes are not uniform across a multinational RPT trial. Access disparities are especially pronounced at a global level: the International Atomic Energy Agency has documented that in some low- and middle-income countries, a single SPECT scanner may serve 33 million people, compared with approximately 57,000 in high-income countries ^[16]. That gap shapes where RPT trials can realistically recruit and where multinational expansion is feasible.

The Biomarker Prescreening Step

The VISION trial's PSMA-PET eligibility requirement was not procedural convenience; it was mechanistically necessary. A patient whose tumor does not express sufficient PSMA will not accumulate the radioligand at therapeutic levels, making treatment both ineffective and potentially exposing the patient to unnecessary radiation burden. The same logic applies across most theranostic programs: the imaging step confirms that the target is present in sufficient density to justify treatment with a radioligand designed for that target.

Biomarker-driven eligibility prescreening is not unique to RPT trials. Companion diagnostic requirements appear in many modern oncology studies, including HER2-targeted therapies and PD-L1-dependent immunotherapy programs. What distinguishes RPT programs is the specific type of prescreening required: nuclear medicine PET imaging using a radioactive tracer, which demands access to a PET scanner and the relevant imaging agent at or near the investigative site, and which introduces a scheduling coordination step between the imaging scan and the treatment dose. That coordination, combined with the isotope half-life constraints described below, can extend the pre-treatment period by days to weeks relative to biomarker screening approaches that use tissue biopsy or blood-based assays.

Isotope Logistics and the Half-Life Problem

Short radioisotope half-lives mean that manufacturing, shipping, site receipt, and patient administration must be tightly coordinated. Lutetium-177 has a half-life of 6.7 days, which allows centralized production and shipping in principle but leaves little margin for delays. As the Pluvicto shortage illustrated, a five-day window from batch release to patient administration means any disruption in manufacturing, customs, or logistics may render a dose unusable ^[18]. Actinium-225 has a half-life of approximately 10 days, creating comparable constraints with a slightly larger buffer.

Protocol-level contingencies for missed doses, rescheduled treatments, and batch failures are essential in RPT trial design and are typically more operationally detailed than in standard chemotherapy or immunotherapy protocols. Sites need to understand the expected batch-release schedule from the manufacturing facility, the maximum allowable elapsed time from release to administration, and the procedure for dose destruction and patient rescheduling.

Curium, one of the larger radiopharmaceutical manufacturers, has projected that reaching up to 6.7 million patients with radioligand therapy over the next decade would require overcoming significant manufacturing and logistics hurdles that the industry is only beginning to address ^[12].

Protocol Complexity: Dosimetry and Safety Monitoring

Unlike chemotherapy dosing, which is typically calculated from body surface area or body weight, radiopharmaceutical dosing is expressed as administered activity in gigabecquerels (GBq) or millicuries (mCi). Both Pluvicto and Lutathera use fixed administered activity. Pluvicto's approved dose is 7.4 GBq administered every six weeks for up to six doses ^[2]; Lutathera's standard adult regimen is 7.4 GBq every eight weeks for four doses ^[9]. Fixed dosing simplifies manufacturing scheduling and clinical operations, but it does not mean dosimetry is irrelevant to clinical development. Radiation absorbed dose to target organs and normal tissues varies by patient based on individual pharmacokinetics, receptor expression density, and body composition. During dosage optimization studies, dosimetry informs whether a proposed administered activity is safe and potentially more effective, which is precisely the challenge the FDA's August 2025 draft guidance on dosage optimization for oncology therapeutic radiopharmaceuticals (Docket FDA-2025-D-1757) was written to address ^[13]. That guidance explicitly acknowledged that organ absorbed dose limits derived from external beam radiotherapy (EBRT) data are not directly applicable to systemically administered radiopharmaceuticals, because the physical properties and treatment delivery mechanisms differ substantially.

For medical writers and protocol developers, the guidance creates a more detailed framework for documenting dosimetry methodology, defining dose-limiting toxicities, and structuring safety monitoring plans. Sponsors proposing to study doses that exceed previously characterized organ tolerances should, per the guidance, discuss such proposals with the FDA in formal meetings early in development. The guidance explicitly does not address selection of the initial administered activity in first-in-human trials; that question remains outside its scope and requires separate regulatory engagement ^[13].

The guidance also notes that RPT can cause delayed, cumulative, or irreversible toxicity. Protocols should include a surveillance period calibrated to the specific agent's known or anticipated toxicity profile, with follow-up schedules designed to capture events that may emerge well after the primary treatment phase has concluded.

Regulatory and Documentation Considerations

FDA Framework for Radiopharmaceuticals

The FDA's regulatory pathway for radiopharmaceuticals draws from both the drug review framework under the Center for Drug Evaluation and Research (CDER) and radiation-specific oversight considerations. Both programs combined conventional efficacy and safety evidence with dosimetry and image-based patient-selection strategies; VISION additionally involved formal companion-diagnostic co-development, with gallium-68 gozetotide approved concurrently for patient eligibility imaging.

The August 2025 draft guidance on dosage optimization represents the most substantive FDA guidance specifically addressing RPT clinical development since CDER published its broader oncology dosage optimization framework in August 2024 ^[13]. The 2025 draft recommends that trials include safeguards covering participant selection, trial design, safety monitoring, and radiation dosimetry evaluation. This is nonbinding guidance, containing recommendations rather than requirements.

The FDA Oncology Center of Excellence partnered with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to organize a Dose Optimization in Radiopharmaceutical Therapy Development Workshop in May 2024, and the August 2025 draft guidance emerged from those discussions ^[14]. A formal commentary published in the Journal of Nuclear Medicine in April 2026 acknowledged that significant questions about how to implement dosimetry-guided dosage optimization in practice remain open, even following the draft guidance ^[14].

Investigational New Drug Applications

Sponsors conducting first-in-human RPT trials must address radiation safety in the IND application in ways that standard oncology drugs do not require. Under 21 CFR 312.23(a)(10)(ii), IND submissions for radioactive drugs must contain sufficient data from animal or human studies to allow a reasonable calculation of radiation-absorbed dose to the whole body and critical organs upon administration to a human subject, and Phase 1 studies of radioactive drugs must include studies that will obtain sufficient data for dosimetry calculations ^[25]. Sponsors typically satisfy this requirement with preclinical biodistribution data extrapolated to humans using validated dosimetry models, though human data from diagnostic analogues may also be used where available. The 2025 draft guidance does not cover initial administered activity selection in first-in-human studies; sponsors should address that topic in early FDA interactions independent of the dosage optimization framework ^[13].

The Investigator Brochure and Evolving Safety Data

RPT programs generate two categories of safety data that must be tracked and reported through the Investigator Brochure: conventional adverse events (fatigue, nausea, cytopenias) and radiation-related toxicities (myelosuppression, renal absorbed dose, long-term risk of myelodysplastic syndrome). The NETTER-1 study reported myelodysplastic syndrome in 2.7% of patients receiving lutetium Lu 177 dotatate at a median follow-up of 24 months ^[9]. Such delayed toxicities require vigilant ongoing pharmacovigilance, with safety data that may continue to accrue well after the primary treatment period and that must be reflected accurately in IB updates as the development program matures. Maintaining cross-document consistency between the protocol's safety monitoring plan, the IB, and any regulatory submissions is where KScribe regulatory document generation is designed to reduce the manual burden.

AI and Automation Perspective

The most immediate application of computational tools in radiopharmaceutical development is dosimetry: using image-derived data from SPECT and PET scans to calculate organ-specific radiation absorbed doses for individual patients. The EANM Dosimetry Committee has issued formal recommendations on patient-specific dosimetry covering normal-organ, tissue, and tumor absorbed doses for 177Lu-labelled somatostatin-receptor and PSMA-targeting ligands, including dosimetry methodology, imaging protocols, absorbed dose calculation, and dose-effect relationships ^[29]. Machine learning approaches to pre-therapy dosimetry prediction have been demonstrated in 177Lu-PSMA I&T therapy: in a retrospective study of 23 patients, models combining pretherapy organ uptake values from PSMA-PET and laboratory measurements showed proof-of-concept ability to predict absorbed doses to the kidneys, liver, salivary glands, and spleen before treatment begins ^[27]. Routine implementation at scale across multi-site trials remains a work in progress, particularly given the need for consistent image acquisition protocols and sufficiently large dosimetry datasets across sites.

Beyond individual dosimetry, AI is being applied to adaptive treatment planning, where tumor response imaging from early treatment cycles informs dose adjustments in subsequent cycles. EANM presentations in 2025 highlighted progress in AI-assisted dosimetry and adaptive planning in 177Lu-PSMA and 177Lu-DOTATATE programs ^[15]. Standardizing how PSMA expression is quantified for eligibility determination across multi-site trials is a recognized challenge, and the 2023 EANM/SNMMI joint procedure guideline for 177Lu-PSMA-RLT acknowledges that patient selection criteria continue to evolve as clinical experience with PSMA-PET eligibility assessments accumulates ^[28].

What AI cannot currently replace in RPT trials is the regulatory judgment involved in designing dosage optimization studies, the radiation safety oversight required at specialized sites, and the cross-disciplinary coordination between nuclear medicine, oncology, regulatory affairs, and clinical operations that these programs demand.

How Kitsa Fits Into This Problem

Two operational challenges in radiopharmaceutical trials where decision support matters most are site identification and protocol documentation. Identifying sites that combine oncology enrollment experience with nuclear medicine infrastructure, companion diagnostic imaging capability, and radiation safety certifications requires layered feasibility intelligence that standard site databases do not capture well. KScout, Kitsa's site selection tool, is designed to surface research site intelligence across that multi-dimensional capability profile, which is particularly relevant for sponsors building site networks for RPT studies where the intersection of oncology and nuclear medicine expertise is the critical constraint.

On the documentation side, RPT protocols carry a higher writing burden than most oncology studies: expanded dosimetry sections, specialized eligibility criteria tied to companion imaging, radiation safety procedures for site staff, and safety monitoring plans that must account for delayed and cumulative toxicity. KScribe is designed to support regulatory document generation, including protocol and Investigator Brochure authoring, in a framework that maintains cross-document consistency as these complex requirements evolve through development.

Key Takeaways

• The FDA approval of Lutathera (January 2018) and Pluvicto (March 2022) established the clinical proof of concept for molecularly targeted radiopharmaceuticals. Lutathera significantly improved progression-free survival in NETTER-1, though the final overall survival analysis did not reach statistical significance (HR 0.84; p=0.30) ^[24]. Pluvicto significantly improved both imaging-based progression-free survival and overall survival in VISION ^[1]. Pluvicto's indication was expanded in March 2025 to pre-taxane mCRPC based on PSMAfore, with Novartis estimating approximately three times as many patients now eligible ^[23].
• Industry-sponsored RPT trials grew 64% between 2019 and 2023, and more than 400 radioligand therapy trials are now registered globally, exploring novel targets and radionuclides beyond the approved lutetium-177 programs.
• Three major pharmaceutical companies entered RPT via acquisition between October 2023 and June 2024: Eli Lilly (POINT Biopharma, ~$1.4B), Bristol Myers Squibb (RayzeBio, ~$4.1B), and AstraZeneca (Fusion Pharmaceuticals, ~$2.4B). All three targets were developing actinium-225-based programs, and supply chain strain from that demand surge has already paused at least one Phase III trial.
• The FDA's August 2025 draft guidance on dosage optimization (FDA-2025-D-1757) establishes new expectations for how sponsors should justify administered activity in RPT trials, moves the field away from direct application of EBRT organ tolerance limits, and clarifies that initial first-in-human dose selection falls outside its scope.
• Site qualification for RPT trials requires nuclear medicine infrastructure, radiation safety personnel, and companion imaging capability that many otherwise well-qualified oncology sites do not have, with jurisdiction-specific radioactive materials regulations adding a further layer of site authorization complexity.
• The biomarker prescreening step in theranostic programs, while not unique to RPT, requires nuclear medicine PET imaging specifically, introducing scheduling dependencies between imaging and treatment that extend the pre-treatment period and require coordination with isotope supply logistics.
• AI-assisted dosimetry and adaptive treatment planning are active areas of development, though clinical implementation at scale across multi-site trials is still maturing.

FAQ

What is the difference between a radiopharmaceutical and traditional targeted therapy?

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Both target tumor-specific proteins, but they deliver different payloads. Targeted therapies such as kinase inhibitors work by blocking a protein's biological function. Radiopharmaceuticals attach a radioactive isotope to a targeting molecule, so when the molecule binds to its receptor on the tumor cell, it delivers ionizing radiation directly to that cell. The distinction matters for trial design because radiopharmaceuticals involve radiation safety considerations that do not apply to conventional small molecule or biologic therapies. Approved programs such as Pluvicto and Lutathera use fixed administered activity and require PSMA-PET or somatostatin receptor imaging for patient selection, though the specific eligibility, dosimetry, and monitoring requirements vary by product and protocol.

What is theranostics?

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Theranostics refers to programs that use the same molecular target for both diagnosis (through imaging) and therapy (through radiation delivery), often with identical or closely related targeting ligands. In a theranostic program for prostate cancer, gallium-68 gozetotide (68Ga-PSMA-11) is used in PET imaging to identify patients whose tumors express PSMA at sufficient levels, and lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) targets the same antigen for therapeutic radiation delivery. While both ligands bind PSMA, they are structurally distinct molecules, not identical compounds in different radiolabeled forms.

Why did Bristol Myers Squibb's RayzeBio pause its Phase III trial in 2024?

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A shortage of actinium-225, the isotope used in their radioconjugate program, forced the trial pause. Actinium-225 has been supplied primarily by Oak Ridge National Laboratory for nearly three decades. As multiple large pharmaceutical companies simultaneously advanced actinium-225-based programs into late-stage development following the 2023 to 2024 acquisition wave, demand began to exceed available production capacity ^[7]. The disruption highlighted a structural vulnerability in the RPT field: the isotope supply chains for emerging radionuclides remain concentrated in a small number of facilities, and demand expansion from clinical programs can outpace infrastructure investment.

What does the FDA's August 2025 draft guidance on radiopharmaceutical dosage optimization change for sponsors?

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The guidance (FDA-2025-D-1757) addresses the mismatch between traditional EBRT-derived organ tolerance limits and the behavior of systemically administered radiopharmaceuticals. It recommends that sponsors design dosage optimization trials with participant-specific safety monitoring and radiation dosimetry evaluation, and that proposals to study doses exceeding established EBRT organ tolerances be discussed with the FDA in formal meetings early in development ^[13]. Importantly, the guidance does not cover selection of the initial administered activity in first-in-human trials; sponsors developing first-in-human RPT programs must address that question through separate regulatory engagement. The guidance contains nonbinding recommendations and is not yet final.

How should sponsors approach site selection for a radiopharmaceutical trial?

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Site selection for RPT studies requires evaluating nuclear medicine department capacity and equipment (gamma cameras, SPECT/CT, PET/CT), radiation pharmacy or hot lab access, radiation safety officer availability, site staff experience with radioactive materials handling, and existing authorizations under national or regional radioactive materials regulations. Sites qualified for standard oncology trials may not hold the necessary radiation licenses or have the physical infrastructure for radiopharmaceutical administration. Radioactive materials regulations differ by country and in some jurisdictions require dedicated GMP manufacturing capability on-site, which can exclude otherwise well-qualified academic centers ^[11]. Centralized radiopharmacy sourcing, where one facility supplies unit-dosed radioligands to multiple sites, is an increasingly common approach to broadening the feasible site pool while managing radiation handling complexity.

Can radiopharmaceuticals be used outside oncology?

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Yes. While oncology represents the dominant current application, theranostic approaches are being investigated in neurodegenerative diseases, cardiovascular conditions, and inflammatory diseases. A 2025 review in Signal Transduction and Targeted Therapy noted that radiotheranostics applications are expanding beyond cancer to include these additional therapeutic areas, with diagnostic radiopharmaceuticals playing a role in patient stratification and treatment planning across disease contexts ^[17].

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