{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T17:43:57Z","timestamp":1790963037575,"version":"4.1.0"},"reference-count":20,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:00:00Z","timestamp":1771459200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Telix Pharmaceuticals","award":["NCT06090331"],"award-info":[{"award-number":["NCT06090331"]}]},{"name":"National Cancer Institute","award":["K08CA259626"],"award-info":[{"award-number":["K08CA259626"]}]},{"name":"National Cancer Institute","award":["K08CA249047"],"award-info":[{"award-number":["K08CA249047"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background: Indeterminate renal masses (IRMs) frequently require biopsy for characterization and often lead to unnecessary surgical interventions. 89Zr-girentuximab is a positron emission tomography (PET) radiopharmaceutical targeting carbonic anhydrase IX, a biomarker overexpressed in clear-cell renal cell carcinoma (ccRCC). This real-world experience demonstrates the impact of 89Zr-girentuximab PET on the clinical management of patients with IRM and its role in differentiating primary and metastatic ccRCC from other etiologies. Methods: This prospective single-center study, part of an expanded access program (NCT06090331), investigated patients with IRM on conventional imaging who underwent 89Zr-girentuximab PET\/computed tomography (PET\/CT). Qualitative and quantitative PET\/CT features of each lesion were assessed. Pathologic or clinical diagnosis was determined for all lesions. Referring physicians were surveyed to evaluate the impact of PET on patient management. Results: Seven male patients (age range, 57\u201378 years) were included; four had ccRCC (including two with metastatic disease) and three had oncocytoma (including one with Birt-Hogg-Dub\u00e9 syndrome). Across all 32 lesions identified, 89Zr-girentuximab PET\/CT accurately characterized each lesion based on pathologic or clinical diagnosis. 89Zr-girentuximab PET\/CT identified ccRCC tumor thrombi in the inferior vena cava and renal vein branches (SUVmax 12.0\u201313.0), a perinephric deposit (SUVmax 36.4), and intramuscular (SUVmax 103.0), pulmonary (SUVmax 4.0\u201310.5), and osseous (SUVmax 10.2) metastases. 89Zr-girentuximab PET\/CT enabled the diagnosis of oncocytomatosis in one patient and detected a renal lesion with positive uptake that was occult on MRI. According to referring physicians, 89Zr-girentuximab PET\/CT changed clinical management in six of seven patients and improved patient care in all cases. Conclusions:\u00a089Zr-girentuximab PET\/CT provides a noninvasive tool for characterizing indeterminate renal masses and metastatic ccRCC and may improve clinical problem-solving in complex scenarios.<\/jats:p>","DOI":"10.3390\/pharmaceutics18020258","type":"journal-article","created":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T09:55:31Z","timestamp":1771494931000},"page":"258","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["89Zr-girentuximab PET\/CT Enables Noninvasive Assessment of Indeterminate Renal Masses and Metastatic Clear-Cell Renal Cell Carcinoma"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9486-3365","authenticated-orcid":false,"given":"Yihan","family":"Cao","sequence":"first","affiliation":[{"name":"Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Talluto","sequence":"additional","affiliation":[{"name":"Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-6720-1615","authenticated-orcid":false,"given":"Taylor","family":"McVeigh","sequence":"additional","affiliation":[{"name":"Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"Blute","sequence":"additional","affiliation":[{"name":"Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas M.","family":"Dahl","sequence":"additional","affiliation":[{"name":"Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keyan","family":"Salari","sequence":"additional","affiliation":[{"name":"Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6383-465X","authenticated-orcid":false,"given":"Pedram","family":"Heidari","sequence":"additional","affiliation":[{"name":"Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6077-4580","authenticated-orcid":false,"given":"Shadi A.","family":"Esfahani","sequence":"additional","affiliation":[{"name":"Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,19]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"139","DOI":"10.2214\/AJR.10.5920","article-title":"Incidental finding of renal masses at unenhanced CT: Prevalence and analysis of features for guiding management","volume":"197","author":"Pickhardt","year":"2011","journal-title":"AJR Am. 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