Journal of nuclear medicine : official publication, Society of Nuclear Medicine最新文献

{"title":"World Health Assembly Resolution WHA78.13 \"Strengthening Medical Imaging Capacity\": Impact on Nuclear Medicine Globally.","authors":"John O Prior, May Abdel-Wahab, Savvas Frangos, Hedvig Hricak, Andrew M Scott","doi":"10.2967/jnumed.125.271611","DOIUrl":"10.2967/jnumed.125.271611","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"672-673"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AI Disclosure Policies: Are We Rearranging Deck Chairs on the Titanic?","authors":"Tyler J Bradshaw","doi":"10.2967/jnumed.125.271870","DOIUrl":"10.2967/jnumed.125.271870","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"827"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phase 2 Prospective Trial of Retreatment with [¹⁷⁷Lu]Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration-Resistant Prostate Cancer-RE-LuPSMA.","authors":"John Nikitas, Adrien Holzgreve, Jesus Juarez, Koichiro Kimura, Stephanie Lira, Hamzah Alam, Maria Contreras, Lela Theus, Andrew T Nguyen, Zachary Ells, Shaojun Zhu, Tristan Grogan, David A Elashoff, Lena M Unterrainer, Magnus Dahlbom, Martin Allen-Auerbach, Johannes Czernin, Jeremie Calais","doi":"10.2967/jnumed.125.271231","DOIUrl":"10.2967/jnumed.125.271231","url":null,"abstract":"<p><p>[¹⁷⁷Lu]Lu-PSMA-617 radiopharmaceutical therapy has been approved for the treatment of patients with metastatic castration-resistant prostate cancer for up to 6 cycles. Unfortunately, this treatment is not curative and patients experience relapse, even after initially favorable responses. When this occurs, patients have limited treatment options. Readministration of [¹⁷⁷Lu]Lu-PSMA-617 in patients who previously benefited from therapy and had limited toxicity seems to be a promising option, with retrospective studies reporting favorable outcomes. <b>Methods:</b> RE-LuPSMA is an investigator-initiated, single-arm, single-center, open-label, phase 2 clinical trial designed to study the efficacy and safety of rechallenge therapy using [¹⁷⁷Lu]Lu-PSMA-617 in patients whose disease progressed after responding well to a previous regimen of [¹⁷⁷Lu]Lu-PSMA-617. This study plans to enroll 40 patients with progressive metastatic castration-resistant prostate cancer who previously completed 4-6 cycles of [¹⁷⁷Lu]Lu-PSMA-617 with a favorable response (i.e., ≥50% decrease in prostate-specific antigen [PSA] level at any point during the first [¹⁷⁷Lu]Lu-PSMA-617 regimen). After the first regimen of [¹⁷⁷Lu]Lu-PSMA-617, patients must meet VISION trial criteria on a prostate-specific membrane antigen (PSMA) PET/CT scan within 8 wk of the planned first cycle of rechallenge therapy. After enrollment, participants will receive up to 6 additional cycles of [¹⁷⁷Lu]Lu-PSMA-617 (7.4 GBq every 6 wk). The primary endpoint is 12-mo overall survival (OS), measured from the start of rechallenge therapy. The study will have 80% power to detect a difference between the null hypothesis of 50% OS at 12 mo and the study hypothesis of 71% OS at 12 mo. Secondary endpoints include adverse-event rates, PSA response rates (proportion of patients with a decrease of 50% or greater in PSA level), biochemical progression-free survival (defined as the time until PSA level increases 25% and 2 ng/mL above the nadir), radiographic progression-free survival, and quality-of-life changes (measured using Functional Assessment of Cancer Therapy-Radionuclide Therapy and Brief Pain Inventory-Short Form). Enrollment began in August 2024, with a planned study duration of 45 mo.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"674-680"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13138109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical ^203/212Pb-DOTA-Based Pretargeted Radioimmunotherapy in Nude Mice Bearing Established Human Colorectal Cancer Xenografts.","authors":"Brett A Vaughn, Darren R Veach, Daniela Burnes Vargas, Shin Seo, Blesida Punzalan, Sara S Rinne, Edward K Fung, Hong Xu, Hong-Fen Guo, Guangbin Yang, Ouathek Ouerfelli, Sebastian E Carrasco, Samantha St Jean, Nai-Kong V Cheung, Steven M Larson, Sarah M Cheal","doi":"10.2967/jnumed.125.270604","DOIUrl":"10.2967/jnumed.125.270604","url":null,"abstract":"<p><p>The ²⁰³Pb (half-life [t_1/2], 51.9 h) and ²¹²Pb (t_1/2 = 10.6 h) theranostic pair shows great potential for radiopharmaceutical therapy. We have developed a highly versatile pretargeted radioimmunotherapy (PRIT) platform that utilizes antitumor antigen/anti-DOTA bispecific antibodies (BsAbs) in combination with rapidly clearing, low-molecular-weight DOTA-radiohaptens (DOTA-PRIT). In this study, we tested the hypothesis that high-therapeutic index (TI) targeting of ²¹²Pb (an in vivo generator of α-emitting progeny, specifically ²¹²Bi (t_1/2 = 1.01 h) and ²¹²Po (t_1/2 = 0.3 µs), and its imaging surrogate, ²⁰³Pb (γ-emitter, 279 keV), would be feasible with anti-glycoprotein A33 (GPA33) DOTA-PRIT for treatment of human colorectal cancer (CRC). <b>Methods:</b> For efficient and stable chelation of lead and high-affinity recognition by BsAbs, we synthesized a TCMC-based radiohapten precursor named TCMC-<i>Proteus</i> (TCMC-Pr). We prepared [²¹²Pb]Pb-TCMC-Pr and confirmed its stability in vitro and recognition by BsAbs. Using the ²⁰³Pb analog, we conducted serial biodistribution and SPECT/CT imaging studies with a 3-step GPA33 DOTA-PRIT approach and extrapolated dosimetry for ²¹²Pb. We then established anti-GPA33 ²¹²Pb-DOTA-PRIT in mouse xenografts of human CRC (GPA33-expressing SW1222). <b>Results:</b> TCMC-Pr was successfully radiolabeled with ²⁰³Pb/²¹²Pb and verified stable in serum, and specific BsAb binding was confirmed. For GPA33-pretargeted [²⁰³Pb]Pb-TCMC-Pr, the blood, SW1222 tumor, and kidney uptakes at 24 h after injection were 0.27 ± 0.14 %IA/g, 8.04 ± 2.94 %IA/g, and 0.88 ± 0.14 %IA/g, respectively. ²¹²Pb doses to tumor, blood, and kidneys were 12,723 mGy/MBq, 313 mGy/MBq (TI, 40.6), and 1,075 mGy/MBq (TI, 11.8), respectively. During ²¹²Pb-DOTA-PRIT therapy studies, we established efficacy and identified a double-cycle treatment regimen (938 kBq + 938 kBq separated by 48 h; total, 1.88 MBq) that led to prolonged survival including 3 of 5 histologic cures at the study endpoint of 137 d. Mice in this treatment group exhibited normal bone marrows and moderate tubulointerstitial lesions, with overall preserved renal function. <b>Conclusion:</b> We have developed a safe, curative GPA33-targeted ²¹²Pb-DOTA-PRIT treatment in a preclinical model of human CRC. This research underscores the potential of ^203/212Pb-DOTA-PRIT in managing CRC and provides a road map for its modular application to other human tumor target antigens compatible with DOTA-PRIT.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"700-708"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13138092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biochemical Recurrence-Free Survival After Radical Prostatectomy in Patients with High-Risk Prostate Cancer: A Nationwide Study of PSMA PET/CT Versus Conventional Imaging.","authors":"Anna W Mogensen, Christian Torp-Pedersen, Mette Nørgaard, Lars J Petersen, Peter B Østergren, Helle D Zacho","doi":"10.2967/jnumed.125.271423","DOIUrl":"10.2967/jnumed.125.271423","url":null,"abstract":"<p><p>Prostate-specific membrane antigen (PSMA) PET/CT offers excellent accuracy in the staging of high-risk prostate cancer (PCa), yet outcomes-based evidence of the clinical benefit remains limited. We aimed to determine whether the rates of biochemical recurrence-free survival (BRFS) are influenced by PSMA-based staging compared with that of conventional imaging among patients undergoing radical prostatectomy (RP), using real-world data and exploiting regional variation in the adoption of PSMA PET/CT across Denmark. <b>Methods:</b> This nationwide cohort study included men with high-risk PCa who underwent RP between 2016 and 2023. Patients were classified on the basis of whether they underwent PSMA PET/CT or conventional imaging before surgery. The primary outcome was BRFS, with overall survival as the secondary outcome. The outcomes were analyzed by inverse probability weighting and adjusted Cox proportional hazards regression analyses. <b>Results:</b> Among 3,279 eligible patients with high-risk PCa who underwent RP, 959 (29.3%) underwent preoperative PSMA PET/CT. This group had a higher 5-y BRFS rate than did the conventional imaging group (65.1%; 95% CI, 61.4%-68.7% vs. 61.1%; 95% CI, 58.9%-63.2%, respectively; weighted hazard ratio, 0.82; 95% CI, 0.70-0.96; <i>P</i> = 0.014). The difference was most pronounced in patients with Gleason scores of 8-10, with 62.5% in the PSMA PET/CT group (95% CI, 57.7%-67.2%) versus 48.9% in the conventional imaging group (95% CI, 44.9%-52.9%; hazard ratio, 0.61; 95% CI, 0.51-0.74; <i>P</i> < 0.001). Overall survival was also greater in the PSMA PET/CT group; however, the limited follow-up prohibited any firm conclusions. The main limitation of this study was its observational design. <b>Conclusion:</b> The use of PSMA PET/CT for high-risk PCa staging was associated with increased BRFS rates.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"724-730"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146184004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to \"AI Disclosure Policies: Are We Rearranging Deck Chairs on the Titanic?\"","authors":"Wolfgang Andreas Weber","doi":"10.2967/jnumed.125.271951","DOIUrl":"10.2967/jnumed.125.271951","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"827-828"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Noninvasive Quantification of [¹⁸F]SynVesT-2 PET in Healthy Human Brains Using Simplified Reference Tissue Models.","authors":"Nira Hernández-Martín, Tutukhanim Balayeva, Mika Naganawa, Ruth H Asch, Yiyun Huang, Richard E Carson, Jean-Dominique Gallezot, Zhengxin Cai","doi":"10.2967/jnumed.125.271207","DOIUrl":"10.2967/jnumed.125.271207","url":null,"abstract":"<p><p>PET imaging of synaptic vesicle glycoprotein 2A (SV2A) has proven to be a powerful research tool for neurologic disorders. Dynamic SV2A PET scans provide data related to cerebral blood flow and SV2A density, which have been shown to be altered in neurologic disorders such as Alzheimer disease. [¹⁸F]SynVesT-2, an SV2A PET tracer, has demonstrated fast brain kinetics and high specific binding in human brains. To improve clinical feasibility, we evaluated the performance of 3 simplified reference tissue models (SRTMs) in the quantification of [¹⁸F]SynVesT-2 PET data and the minimum scan times required for reliable estimation of relative cerebral blood flow and SV2A density. <b>Methods:</b> Data were pooled from 14 [¹⁸F]SynVesT-2 scans acquired from 9 healthy volunteers. An SRTM, SRTM with a fitted regionally coupled <i>k'</i> ₂ (SRTMC), and SRTM with a population-based <i>k'</i> ₂ (SRTM2) with the centrum semiovale and cerebellum as reference regions were used to calculate nondisplaceable binding potential (BP_ND) and distribution volume ratio (DVR), respectively, as well as the relative tracer delivery rate (<i>R</i> ₁). Test-retest variability (TRV), absolute TRV, and the minimum scan duration for the reliable estimation of <i>R</i> ₁, BP_ND, and DVR were additionally evaluated. <b>Results:</b> Despite time-activity curves being well-described by all 3 models, SRTM generated unreliable BP_ND and DVR values in 9% and 12% of the regions of interest, respectively. SRTMC and SRTM2 resulted in BP_ND and DVR values consistent with those generated from the 1-tissue compartment model. On the basis of the time stability analysis, BP_ND and DVR estimated using SRTM2 converged after 40 min. Using SRTM2, the TRV and absolute TRV estimated from 40-min dynamic scans were -1.0 ± 11.5% and 9.9 ± 5.8% for BP_ND and 1.7 ± 4.0% and 3.6 ± 2.5% for DVR. <b>Conclusion:</b> The parameters of relative cerebral blood flow (<i>R</i> ₁) and specific binding (BP_ND and DVR) can be reliably estimated from a 40-min dynamic [¹⁸F]SynVesT-2 PET scan by SRTM2, which is 30 min shorter than that required for [¹¹C]UCB-J and [¹⁸F]SynVesT-1. The shortened scan time enables the clinical application of dynamic SV2A PET scans to maximize the physiologically relevant information attainable from a single scan.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"796-802"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13138105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":"67 5","pages":"830"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147825121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical Evaluation of [¹⁷⁷Lu]Lu-ART-101 for Radiopharmaceutical Therapy of Advanced Prostate Cancer.","authors":"Malick Bio Idrissou, Carolina Aguiar Ferreira, Hansel Comas Rojas, Liudmila H Lambert Lepesevich, Lauren E Wehner, Nathan Clemons, Yadira Medina-Guevara, Elizabeth Santos, Andres F Mejia Montoya, Christopher Massey, Amanda Carston, John Munson, Anatoly N Pinchuk, Gopal Iyer, Reinier Hernandez","doi":"10.2967/jnumed.125.271543","DOIUrl":"10.2967/jnumed.125.271543","url":null,"abstract":"<p><p>Radiopharmaceutical therapy with [¹⁷⁷Lu]Lu-PSMA-617 has improved outcomes for patients with advanced prostate cancer (PCa), yet modest survival benefits underscore the need for more effective agents. Here, we describe the development of [¹⁷⁷Lu]Lu-ART-101, a next-generation prostate-specific membrane antigen (PSMA)-targeting radioligand, and evaluate its biodistribution, dosimetry, therapeutic efficacy, and toxicity in advanced PSMA-expressing PCa models. <b>Methods:</b> Lipophilic ART-101 was synthesized and radiolabeled with ¹⁷⁷Lu. [¹⁷⁷Lu]Lu-ART-101 longitudinal biodistribution and dosimetry were assessed through SPECT/CT imaging in human PC3-PIP (PC3 cells engineered to overexpress PSMA) xenograft-bearing mice and compared with those of [¹⁷⁷Lu]Lu-PSMA-617. The therapeutic efficacy of [¹⁷⁷Lu]Lu-ART-101 was evaluated in the PC3-PIP and LNCaP xenograft-bearing mice, whereas toxicity was assessed in normal ICR mice. <b>Results:</b> [¹⁷⁷Lu]Lu-ART-101 demonstrated patterns of cell binding and internalization similar to those of [¹⁷⁷Lu]Lu-PSMA-617 in PC3-PIP cells. Internalization was effectively blocked by PSMA-617, indicating the PSMA-specific binding of [¹⁷⁷Lu]Lu-ART-101. In vitro competition assays revealed potent nanomolar binding, with unlabeled ART-101 competitively displacing [¹⁷⁷Lu]Lu-PSMA-617, with 0.4 ± 0.1 nM of inhibitory concentration of 50%, in PC3-PIP cells. In nude mice bearing PC3-PIP xenografts, [¹⁷⁷Lu]Lu-ART-101 displayed higher tumor uptake (peak at 14.3 ± 1.5 %IA/g at 48 h after injection) and prolonged retention (8.1 ± 0.8 and 6.4 ± 1.0 %IA/g at 120 and 168 h, respectively) versus [¹⁷⁷Lu]Lu-PSMA-617 (peak at 10.0 ± 2.0 %IA/g at 2 h) followed by a rapid decrease (2.2 ± 1.5 %IA/g at 120 h), leading to a 2-fold higher tumor absorbed dose with [¹⁷⁷Lu]Lu-ART-101 (1.2 ± 0.1 vs. 0.6 ± 0.1). Notably, [¹⁷⁷Lu]Lu-ART-101 showed a distinctive normal tissue distribution compared with [¹⁷⁷Lu]Lu-PSMA-617, with longer blood circulation, negligible salivary gland uptake, and primarily hepatic rather than renal clearance. [¹⁷⁷Lu]Lu-ART-101's favorable tumor dosimetry translated to enhanced tumor control and prolonged survival in both the PC3-PIP and LNCaP xenograft models. Safety studies in ICR mice revealed mild transient cytopenia in animals receiving the highest tested injected activity (55.5 MBq), which resolved by day 28, without concomitant renal, hepatic, or histologic abnormalities, including those in the bone marrow and salivary glands. <b>Conclusion:</b> [¹⁷⁷Lu]Lu-ART-101 demonstrates significant potential as a novel radiopharmaceutical for advanced PCa, with superior therapeutic efficacy and a favorable safety profile. These findings support our ongoing clinical translation effort in advanced PCa.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":"758-764"},"PeriodicalIF":9.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147313832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Equivalents Are Coming! Developing a Shared Nomenclature for Radiopharmaceutical Therapy of Neuroendocrine Tumors, Prostate Cancer, and Beyond.","authors":"Aman Chauhan, Andrew E Hendifar, Ghassan El-Haddad, Heloisa P Soares, Ken Herrmann","doi":"10.2967/jnumed.126.272026","DOIUrl":"https://doi.org/10.2967/jnumed.126.272026","url":null,"abstract":"<p><p>As radiopharmaceutical therapy (RPT) expands beyond neuroendocrine tumors and prostate cancer, it is important to understand the U.S. Food and Drug Administration (FDA) approval process and to establish a shared vocabulary for effective communication. The 505(b)(2) New Drug Application is a well-established mechanism for FDA approval of nuclear medicine products. It is an application for drugs that are similar to an approved product, supported by published literature and studies conducted on similar drugs, and bridging studies demonstrating the scientific relevance of the data to the product. This streamlined approval pathway can encourage development of more treatment options, facilitating greater patient access and improved resilience to supply chain disruptions. The evolving RPT landscape necessitates new nomenclature. \"Radioligand equivalent\" refers to an RPT approved through the 505(b)(2) pathway, distinct from a generic RPT approved through an Abbreviated New Drug Application. Establishing shared terminology supports clear multidisciplinary communication and fosters informed treatment selection.</p>","PeriodicalId":94099,"journal":{"name":"Journal of nuclear medicine : official publication, Society of Nuclear Medicine","volume":" ","pages":""},"PeriodicalIF":9.1,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147825134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}