EJNMMI Radiopharmacy and Chemistry最新文献

{"title":"Lung perfusion imaging in nuclear medicine with ^99mTc: a comprehensive survey of radiopharmaceuticals.","authors":"Hassan Zareian, Mehrnaz Mardazad, Mahshid Kiani, Nafise Pourshafagh, Fateme Karimi, Mehdi Shafee Ardestani","doi":"10.1186/s41181-026-00434-2","DOIUrl":"https://doi.org/10.1186/s41181-026-00434-2","url":null,"abstract":"<p><strong>Background: </strong>Technetium-99 m-labeled macroaggregated albumin ([⁹⁹ᵐTc]Tc-MAA) is the standard agent for lung perfusion imaging in pulmonary embolism (PE). Limitations related to particle consistency, preparation procedures, and blood-derived origin have prompted the development of alternative non-blood-derived tracers.</p><p><strong>Main body: </strong>A narrative review of studies up to August 2025 was performed. Candidate radiopharmaceuticals were evaluated for pulmonary localization, physicochemical properties, quality control characteristics, radiopharmacy practicality, kit-based preparation, and preclinical or clinical validation. Biodegradable microspheres, synthetic colloids, starch-based microparticles, and small-molecule complexes demonstrated promising lung uptake. Most tracers, however, lacked standardized preparation, kit compatibility, or validation in PE-relevant models. Starch-based microparticles emerged as the most translationally promising, showing practical workflow and favorable biodistribution.</p><p><strong>Conclusion: </strong>No non-blood-derived ⁹⁹ᵐTc tracer currently matches [⁹⁹ᵐTc]Tc-MAA for routine lung perfusion imaging. Future development requires standardized, pharmacopeia-aligned tracers, head-to-head comparisons, and systematic evaluation in early-phase clinical trials.</p>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580175","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":"Preliminary biological evaluation of a [177Lu]Lu-labeled peptide targeting Nectin-4","authors":"Dengke Li,&nbsp;Yu Zhang,&nbsp;Chao Mu,&nbsp;Xuecen Cao,&nbsp;Mumei Chen,&nbsp;Xiao Li,&nbsp;Wenxin Chen,&nbsp;Zheng Li","doi":"10.1186/s41181-026-00435-1","DOIUrl":"10.1186/s41181-026-00435-1","url":null,"abstract":"<div><h3>Background</h3><p>Despite the clinical implementation of Nectin-4-targeted antibody-drug conjugates (ADCs) and radioligand therapies (RLTs), their therapeutic window is often restricted by systemic toxicities and the emergence of drug resistance. To circumvent these limitations, we developed [¹⁷⁷Lu]Lu-DOTA-AC-SP, a novel peptide-based radiopharmaceutical specifically engineered for the targeted treatment of Nectin-4-expressing malignancies.</p><h3>Results</h3><p>The synthesis of [¹⁷⁷Lu]Lu-DOTA-AC-SP was achieved with high radiochemical purity and excellent stability in vitro. Pharmacokinetic evaluations revealed a favorable profile characterized by high binding affinity and rapid systemic clearance. In vivo biodistribution studies demonstrated significant tumor accumulation and prolonged retention, resulting in superior target-to-background ratios. Furthermore, [¹⁷⁷Lu]Lu-DOTA-AC-SP exhibited robust anti-tumor efficacy in Nectin-4-positive models, maintaining an excellent safety profile with minimal off-target effects.</p><h3>Conclusions</h3><p>These findings characterize [¹⁷⁷Lu]Lu-DOTA-AC-SP as a potent and safe therapeutic candidate for Nectin-4-positive tumors. Its favorable pharmacokinetic properties and significant therapeutic index support its potential clinical translation as a next-generation treatment for urothelial carcinoma (UC).</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13035971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571760","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":"Highlight selection of radiochemistry and radiopharmacy developments by editorial board","authors":"Oliver C. Kiss,&nbsp;Ivan Penuelas,&nbsp;Ana Rey,&nbsp;Zhi Yang,&nbsp;Nic Gillings,&nbsp;Ambi Pillai,&nbsp;Emiliano Cazzola,&nbsp;Raymond M. Reilly,&nbsp;Carlotta Taddei,&nbsp;Jeff Liu,&nbsp;Michael van Dam,&nbsp;Shozo Furumoto,&nbsp;Junbo Zhang,&nbsp;Emerson Soares Bernardes,&nbsp;Filippo Lodi,&nbsp;Winnie Deuther-Conrad,&nbsp;Ya-Yao Huang,&nbsp;Yohannes Jorge Lagebo,&nbsp;Fany P. Ekoume,&nbsp;Miguel A. Avila-Rodriguez,&nbsp;Beverley Summers,&nbsp;Amal Elrefaei,&nbsp;Maria Salgueiro,&nbsp;Catarina F. Ramogida,&nbsp;Peter J. H. Scott","doi":"10.1186/s41181-026-00443-1","DOIUrl":"10.1186/s41181-026-00443-1","url":null,"abstract":"<div><h3>Background</h3><p>The Editorial Board of EJNMMI Radiopharmacy and Chemistry releases a biannual highlight commentary to update the readership on trends in the field of radiopharmaceutical development and application of radiopharmaceuticals.</p><h3>Main body</h3><p>This selection of highlights provides commentary on 25 different topics selected by each co-authoring Editorial Board member addressing a variety of aspects ranging from novel radiochemistry to first-in-human application of novel radiopharmaceuticals.</p><h3>Conclusion</h3><p>Trends in radiochemistry and radiopharmacy are highlighted. Hot topics cover the entire scope of EJNMMI Radiopharmacy and Chemistry, demonstrating the progress in the research field in many aspects.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00443-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147508485","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":"An improved fully-automated GMP radiosynthesis of [18F]fluoro-pivalic acid with solid-phase extraction purification","authors":"Chris Barnes,&nbsp;Frazer Twyman,&nbsp;Ramla O. Awais,&nbsp;Dylan Pritchard,&nbsp;Matthias Glaser,&nbsp;David R. Turton,&nbsp;Diana Brickute,&nbsp;Graham Smith,&nbsp;Erik Årstad,&nbsp;Louis Allott,&nbsp;Eric O. Aboagye","doi":"10.1186/s41181-026-00440-4","DOIUrl":"10.1186/s41181-026-00440-4","url":null,"abstract":"<div><h3>Background</h3><p>We previously reported the first-in-human evaluation of 3-[¹⁸F]-fluoro-2,2-dimethylpropionic acid ([¹⁸F]FPIA) for imaging aberrant lipid metabolism and cancer detection. The first-generation semi-automated radiosynthesis of [¹⁸F]FPIA required HPLC purification to provide injection solution devoid of precursor (methyl 2,2-dimethyl-3-[(4-methylbenzenesulfonyl)oxy]propanoate), radioactive intermediate (methyl-3-([18F]fluoro)-2,2-dimethylpropanoate), and potential chemical impurities (tosic acid, 3-hydroxy-2,2-dimethylpropanoic acid and unlabelled FPIA). In readiness for global use of [¹⁸F]FPIA, we report a significant improvement to the GMP production through development of a fully-automated solid-phase extraction (SPE) purification method.</p><h3>Results</h3><p>We developed a fully-automated SPE purified radiosynthesis on FASTLab™ for GMP readiness that was translated to and validated on the Trasis AIO™ platform for routine clinical use. Purification of the radiotracer by SPE on both systems was achieved (&gt; 98% radiochemical purity), increasing the radiochemical yield compared to the HPLC-based purification method. Non-decay-corrected radiochemical yields (RCY, n.d.c) were 30.3 ± 2.3% (n = 8) and 25.8 ± 6.6% (n = 46) on GE FASTlab™ and Trasis AIO™, respectively. Non-radioactive FPIA and other analytes determined by HPLC were below the limit of detection (&lt; 1.0 µg/mL) from GE FASTlab™ and ≤ 1.2 µg/mL from Trasis AIO™.</p><h3>Conclusions</h3><p>The synthesis of [¹⁸F]FPIA was validated on the Trasis AIO™ platform for GMP production and is currently used to produce clinical doses for phase II clinical trials. Readiness for GMP validation was also demonstrated on GE FASTlab™ and can be adopted on other automated platforms.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00440-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147493296","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":"Increased affinity by dimerization of radiolabeled Affibody molecule ATH001 targeting PDGFRβ","authors":"Ayman Abouzayed,&nbsp;Hugo Olsson,&nbsp;Natalia Papadopoulos,&nbsp;Bogdan Mitran,&nbsp;Hemantha Mallapura,&nbsp;Tahmida Akter,&nbsp;Irina Velikyan,&nbsp;Olle Korsgren,&nbsp;Carl-Henrik Heldin,&nbsp;John Löfblom,&nbsp;Michael Wagner,&nbsp;Olof Eriksson","doi":"10.1186/s41181-026-00439-x","DOIUrl":"10.1186/s41181-026-00439-x","url":null,"abstract":"<div><h3>Background</h3><p>Platelet-derived growth factor receptor–β (PDGFRβ) is a canonical marker of pericytes and stromal cells in most tissues. It is present on cancer associated fibroblasts (CAFs) in the tumor microenvironment and has thus been proposed as a potential therapeutic target both for anti-cancer drugs as well as for radioligand therapy (RLT). ATH001 is a novel Affibody molecule-based radiopharmaceutical in clinical development for targeting of PDGFRβ. We hypothesize that dimerization of ATH001 could improve affinity to PDGFRβ, leading to better characteristics for in vivo targeting. The dimeric construct, named ATH022, was generated by conjugation of two chemically synthesized ATH001 binders to a tri-functional linker comprising a DOTA chelator. Here, we present a comprehensive in vitro and in vivo evaluation of Gallium-68 and Indium-111 labeled ATH022, in direct comparison with ATH001.</p><h3>Results</h3><p>DOTA-ATH022 acted as a PDGFRβ antagonist and competed dose-dependently with the endogenous ligand PDGF-BB. Affinity of the dimer was improved approximately tenfold compared to DOTA-ATH001, mainly due to strongly decreased off-rate. Radiolabeled DOTA-ATH022 demonstrated higher specific binding and longer retention to U87 cells in vitro. Radiolabeled DOTA-ATH022 also exhibited elevated binding in PDGFRβ-positive tissues spleen and U87 tumors, that could be blocked by ATH001 in excess. Binding of DOTA-ATH022 in PDGFRβ avid and well-perfused spleen was 3 times higher than for DOTA-ATH001, but tumor binding was lower. In vivo retention in spleen was 5 times longer for Indium-111 labeled ATH022, in agreement with its in vitro binding characteristics.</p><h3>Conclusions</h3><p>DOTA-ATH022 is a novel dimerized version of ATH001, with significantly improved affinity towards PDGFRβ. Retention of radiolabeled DOTA-ATH022 in PDGFRβ-avid tissues and tumors was increased, however uptake in solid tumor tissue was not improved.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00439-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147466464","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":"The 68Ge/68Ga generator for enhancing productivity and reducing costs in nuclear medicine: experience from a university hospital","authors":"Alessandra Guercio,&nbsp;Tess Martin,&nbsp;Silvia Migliari,&nbsp;Anna Gagliardi,&nbsp;Maura Scarlattei,&nbsp;Giorgio Baldari,&nbsp;Nicolas Martelli,&nbsp;Livia Ruffini","doi":"10.1186/s41181-026-00437-z","DOIUrl":"10.1186/s41181-026-00437-z","url":null,"abstract":"<div><h3>Background</h3><p>Sustainability in healthcare, particularly Nuclear Medicine, is essential, especially in managing radioactive materials. Traditional centralized production of Fluorine-18 tracers for PET imaging faces challenges like transport logistics, decay losses and supply chain vulnerabilities. Decentralized production with radionuclide generators, such as the Germanium-68/Gallium-68 (⁶⁸Ge/⁶⁸Ga) generator, offers on-demand isotope production, improving accessibility and precision imaging. This study evaluates the long-term performance (8 years) of ⁶⁸Ga-based radiopharmaceutical production in a Nuclear Medicine Division, focusing on efficiency, sustainability, and cost.</p><h3>Results</h3><p>Between 2016 and 2024, 416 batches of ⁶⁸GaCl₃ and 2455 batches of ⁶⁸Ga-based radiopharmaceuticals were produced. Data from systematic quality controls on generator eluates and tracers, such as ⁶⁸Ga-PSMA (1800 batches) and ⁶⁸Ga-DOTATOC (610 batches), were evaluated. All ⁶⁸GaCl₃ eluates met Ph. Eur. specifications, with negligible ⁶⁸Ge breakthrough (mean 0.0000068%) and consistently high radiochemical purity (100%). Radiopharmaceuticals showed stable quality over time, with &gt; 98% purity for ⁶⁸Ga-DOTATOC and &gt; 99% for ⁶⁸Ga-PSMA. Generators performance remained reliable, with an average elution yield of 74.8% (range 63.4–84.7%) and up to 466 elutions/year reached in 2024 without quality degradation. The correlation between estimated and measured end-of-synthesis activities was strong (R² ≈ 1), supporting accurate production planning. Clinical PET scans increased over sixfold, from 144 in 2016 to 920 in 2025. The high-sensitivity PET/CT system helped reduce injected activity and acquisition time, improving throughput and sustaining growth. The clinical-to-production ratio progressively decreased from 1 (1 batch/exam) to 0.42 for ⁶⁸Ga-PSMA (range 0.37–0.51) and 0.49 for ⁶⁸Ga-DOTATOC (range 0.40–0.60), indicating better batch utilization and workflow efficiency. Cost analysis showed module-based synthesis was most efficient during high-yield phases of the generators, while kit-based approaches were more cost-effective at later stages. Supply logistics of precursors and reagents has shown to be more sustainable for in-house production of radiopharmaceuticals compared to the purchased ones from external facilities.</p><h3>Conclusions</h3><p>The ⁶⁸Ge/⁶⁸Ga generator supports reliable, sustainable, and cost-effective radiopharmaceutical production, enhancing efficiency and clinical capacity in PET imaging.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00437-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147455043","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":"Automated radiosynthesis of 2-[18F]BPA for PET-based planning of boron neutron capture therapy (BNCT): rational precursor design, radiofluorination, and characterization of methodology","authors":"Vincenzo Paolillo,&nbsp;Cong-Dat Pham,&nbsp;Robert Ta,&nbsp;Dimitra K. Georgiou,&nbsp;Henry Charles Manning","doi":"10.1186/s41181-026-00436-0","DOIUrl":"10.1186/s41181-026-00436-0","url":null,"abstract":"<div><h3>Background</h3><p>Boron neutron capture therapy relies on the selective accumulation of boron-containing compounds in tumor tissue, making accurate quantification of boron distribution essential for effective treatment planning. The amino acid analog boronophenylalanine is widely used as a boron delivery agent, yet direct assessment of its biodistribution remains challenging. A fluorine-18 labeled analog, 2-fluoro-boronophenylalanine, offers the potential to visualize and quantify uptake through positron emission tomography. However, reported radiosynthetic methods often suffer from low radiochemical yield, complex workflows, and limited compatibility with automated production platforms. The aim of this study was to design a stable precursor suitable for nucleophilic fluorination, develop a fully automated single-reactor radiosynthesis, and characterize the resulting tracer to support both preclinical use and future clinical translation.</p><h3>Results</h3><p>A rationally protected precursor incorporating tert-butyloxycarbonyl and pinacol ester groups was synthesized and isolated with high chemical and enantiomeric purity. Using this precursor, an automated single-pot radiosynthesis was implemented on a commercial synthesis module employing copper-mediated nucleophilic fluorination followed by acidic hydrolysis. Across eight production runs, the method yielded 2-fluoro-boronophenylalanine with non-decay-corrected radiochemical yields of 3–5% and a total synthesis time of approximately 60–70 min. Radiochemical purity consistently exceeded 98%, and the molar activity at the end of synthesis ranged from 85 to 120 GBq per micromole. The final formulation remained chemically and radiochemically stable for at least four hours at room temperature. Analytical and chiral chromatographic assessments confirmed product identity, purity, and retention of stereochemical configuration.</p><h3>Conclusions</h3><p>This study establishes a practical and fully automated radiosynthetic approach for producing 2-fluoro-boronophenylalanine using a single-reactor nucleophilic fluorination strategy. The method overcomes key limitations of electrophilic fluorination and multi-pot workflows, provides high radiochemical purity and suitable molar activity, and is compatible with commercially available synthesis equipment. These features support routine preclinical application and position the method for future current good manufacturing practice adaptation to enable clinical use in boron neutron capture therapy planning.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13076846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147353275","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":"Co-57-based intercomparison of TLC scanners and dose calibrators for low-activity radiochemical purity assessment in radiopharmaceutical quality control","authors":"Marietta Straub,&nbsp;Michel Leresche,&nbsp;Claude Pilloud,&nbsp;Rolf Hesselmann,&nbsp;Nicolas Stritt,&nbsp;Ruslan Cusnir","doi":"10.1186/s41181-026-00433-3","DOIUrl":"10.1186/s41181-026-00433-3","url":null,"abstract":"<div><h3>Background</h3><p>Thin layer chromatography scanners and dose calibrators are commonly used to assess radiochemical purity of radiopharmaceutical preparations. Strict quality assurance programs surveyed by regulatory bodies exist for dose calibrators, but they primarily focus on clinical activity ranges, typically tens to hundreds of megabecquerels (MBq). These programs are not designed to evaluate performance at the lower activity levels used during radiopharmaceutical quality control, in the range of just a few MBq or less. For thin layer chromatography scanners, to our knowledge, no supervised quality control program exists. As a result, current practices may overlook potential inaccuracies at these low but critical activity levels, potentially affecting the reliability of radiochemical purity assessments, guaranteeing radiopharmaceutical quality of patient injections.</p><h3>Results</h3><p>To address this gap, in collaboration with the Swiss Federal Office of Public Health, we organized an intercomparison campaign for radiochemical purity testing employing in-house fabricated cobalt-57 (Co-57) strips simulating a chromatogram of a radiopharmaceutical preparation for quality control. Co-57, with its longer half-life, closely simulates the gamma emissions of technetium-99m (Tc-99m), a nuclide widely used in nuclear medicine. Co-57 thin layer chromatography strips were prepared and characterized, before being sent to nuclear medicine centers for measurement and radiochemical purity assessment. 31 centers participated, in total 41 quality control measurements were performed using dose calibrators and/or thin layer chromatography scanners to assess the radiochemical purity. All 27 dose calibrator results were within specifications, except for one result that overestimated the radiochemical purity. Within 14 thin layer chromatography scanner results, 3 were out of tolerance.</p><h3>Conclusion</h3><p>Regular participation in intercomparison campaigns is essential for harmonizing practices and ensuring reproducible, reliable results. Thin layer chromatography results can be affected by scanner settings, procedural variations, and subjective peak integration. By comparing thin layer chromatography scanners and dose calibrators, we identified potential instrument biases and methodological discrepancies when values were out of tolerance. Our intercomparison contributed to improving the performance and comparability of radiochemical purity measurements across Swiss nuclear medicine institutions.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00433-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147353212","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":"Long-term performance evaluation of a novel 3.26 GBq 68Ge/68Ga generator","authors":"Xiaoyang Hu,&nbsp;Renxin Hu,&nbsp;Yao Yang,&nbsp;Yuping Li,&nbsp;Yan Zhao,&nbsp;Ning Liu,&nbsp;Qiang Ge,&nbsp;Shuang Zhang,&nbsp;Songdong Ding","doi":"10.1186/s41181-026-00429-z","DOIUrl":"10.1186/s41181-026-00429-z","url":null,"abstract":"<div><h3>Background</h3><p>⁶⁸Ga is a key radionuclide in PET due to its favorable decay properties, generator availability, and growing preclinical and clinical use of ⁶⁸Ga-labeled radiopharmaceuticals. The performance of the ⁶⁸Ge/⁶⁸Ga generator is critical for efficient ⁶⁸Ga utilization. Here, a novel modified TiO₂-based ⁶⁸Ge/⁶⁸Ga generator (⁶⁸Ge activity: 3.26 GBq) was evaluated for long-term performance, including ⁶⁸Ga elution yield, ⁶⁸Ge breakthrough, and metal impurities (Ti, Fe and Zn), and was verified in radiolabeling applications.</p><h3>Results</h3><p>Over a two-year period, this generator maintained an average ⁶⁸Ga elution yield of 79.8 ± 3.2% (<i>n</i> = 209, range: 70.8%–87.1%), an average ⁶⁸Ge breakthrough as low as 0.00003% (<i>n</i> = 149, range: 0.0000035%–0.00031%), and Ti, Fe, and Zn concentrations well below the limit of 10 µg/GBq. The generator demonstrated compatibility with various precursors such as DOTA-TATE, Pentixafor and FAP-2286.</p><h3>Conclusion</h3><p>The enhancement of the ⁶⁸Ge(IV) loading capacity in the ⁶⁸Ge/⁶⁸Ga generator, along with improved ⁶⁸Ga elution efficiency, facilitates the rapid and efficient production of ⁶⁸Ga. This advancement contributes to the promotion and widespread adoption of ⁶⁸Ga-based radiopharmaceuticals and benefits more patients.</p><h3>Graphical abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00429-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147323971","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":"Ensuring enantiomeric consistency in FAPI radiopharmaceuticals: comparative analysis of (S)- and (S/R)-FAPI-46/-74 confirms pharmacological equivalence","authors":"Magdalena Staniszewska,&nbsp;Ralph Hübner,&nbsp;Camilla Locatelli,&nbsp;Douglas Howard,&nbsp;Matilde Forni,&nbsp;Francis Man,&nbsp;Bent Wilhelm Schoultz,&nbsp;Syed Nuruddin,&nbsp;Ingrid Sofie Norberg-Schulz Hagen,&nbsp;Sherly Mosessian,&nbsp;Ken Herrmann,&nbsp;Valeska von Kiedrowski,&nbsp;Katharina Lückerath","doi":"10.1186/s41181-026-00432-4","DOIUrl":"10.1186/s41181-026-00432-4","url":null,"abstract":"<div><h3>Background</h3><p>Enantiomeric composition may impact binding and potentially performance of a drug product but is not routinely tested and minimum acceptance criteria are not always established. Some batches of the precursors FAPI-46 and FAPI-74 used clinically contain a mixture of (<i>S</i>)- and (<i>R</i>)-enantiomers. This study investigates the in vitro pharmacodynamic characteristics of different enantiomeric compositions of FAP-targeting radioligands FAPI-46 and FAPI-74 and in vivo pharmacokinetics of FAPI-46 in naïve mice.</p><h3>Results</h3><p>(<i>S</i>)-, (<i>R</i>)-, and (<i>S/R</i>)-enantiomers of radiolabeled FAPI-46 and FAPI-74 were evaluated for stability in human serum, binding affinity, internalization, retention, and selectivity using HT1080-hFAP cells and HEK293-hCD26 cells. All enantiomeric compositions showed high stability in human serum with minimal serum protein adhesion. (<i>S</i>)- and (<i>S/R</i>)-enantiomers exhibited comparable binding, internalization, and retention characteristics. High selectivity for FAP over CD26/DPP4 was maintained. (<i>R</i>)-enantiomers showed no specific binding to FAP. Additionally, the same enantiomers of ⁶⁸Ga-labeled FAPI-46 were evaluated by dynamic positron emission tomography (PET) imaging (0–60 min post-injection) and ex vivo organ biodistribution in naïve BALB/c mice (10, 30, and 60 min, or 4 h post-injection) to compare their pharmacokinetic profiles. PET imaging revealed nearly identical time-activity curves for the enantiomers of [⁶⁸Ga] Ga-FAPI-46, indicating similar whole-body distribution within 1 h post-injection, with rapid renal clearance and minimal muscle uptake. Ex vivo organ biodistribution confirmed comparable pharmacokinetic profiles between enantiomers, with no significant differences in tissue distribution.</p><h3>Conclusion</h3><p>These findings provide important validation that current clinical (<i>S/R</i>)-mixtures of FAPI-46/-74 exhibit pharmacokinetic and pharmacodynamic behavior comparable to pure (<i>S</i>)-enantiomers, supporting regulatory confidence and cross-trial reproducibility in the global FAPI-46/-74 imaging landscape.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"11 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1186/s41181-026-00432-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147315861","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}