{"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":1790963037038,"version":"4.1.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Telix Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,8,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>PET\/CT imaging with Zirconium-89 labeled [89Zr]Zr-DFO-girentuximab, which targets tumor antigen CAIX, may aid in the differentiation and characterization of clear cell renal cell carcinomas (RCC) and other renal and extrarenal lesions, and has been studied in European and American cohorts. We report results from a phase I study that evaluated the safety profile, biodistribution, and dosimetry of [89Zr]Zr-DFO-girentuximab in Japanese patients with suspected RCC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Eligible adult patients received 37\u00a0MBq (\u00b1 10%; 10\u00a0mg mass dose) of intravenous [89Zr]Zr-DFO-girentuximab. Safety and tolerability profile was assessed based on adverse events, concomitant medications, physical examination, vital signs, hematology, serum chemistry, urinalysis, human anti-chimeric antibody measurement, and 12-lead electrocardiograms at predefined intervals. Biodistribution and normal organ and tumor dosimetry were evaluated with PET\/CT images acquired at 0.5, 4, 24, 72\u00a0h and Day 5\u00a0\u00b1\u00a02\u00a0d after administration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>[89Zr]Zr-DFO-girentuximab was administered in six patients as per protocol. No treatment-emergent adverse events were reported. Dosimetry analysis showed that radioactivity was widely distributed in the body, and that the absorbed dose in healthy organs was highest in the liver (mean\u00a0\u00b1\u00a0standard deviation) (1.365\u00a0\u00b1\u00a00.245\u00a0mGy\/MBq), kidney (1.126\u00a0\u00b1\u00a00.190\u00a0mGy\/MBq), heart wall (1.096\u00a0\u00b1\u00a00.232\u00a0mGy\/MBq), and spleen (1.072\u00a0\u00b1\u00a00.466\u00a0mGy\/MBq). The mean effective dose, adjusted by the radioactive dose administered, was 0.470\u00a0mSv\/MBq. The radiation dose was highly accumulated in the targeted tumor, while any abnormal accumulation in other organs was not reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study demonstrates that [89Zr]Zr-DFO-girentuximab administered to Japanese patients with suspected RCC has a favorable safety profile and is well tolerated and has a similar dosimetry profile to previously studied populations.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyae075","type":"journal-article","created":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T09:03:46Z","timestamp":1718183026000},"page":"873-879","source":"Crossref","is-referenced-by-count":12,"title":["Evaluation of PET\/CT imaging with [89Zr]Zr-DFO-girentuximab: a phase 1 clinical study in Japanese patients with renal cell carcinoma (Zirdac-JP)"],"prefix":"10.1093","volume":"54","author":[{"given":"Noboru","family":"Nakaigawa","sequence":"first","affiliation":[{"name":"Department of Urology, Yokohama City University , Yokohama City, Kanagawa 236-0004 , Japan"},{"name":"Department of Urology, Kanagawa Cancer Center , Yokohama City, Kanagawa 241-8515 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisashi","family":"Hasumi","sequence":"additional","affiliation":[{"name":"Department of Urology, Yokohama City University , Yokohama City, Kanagawa 236-0004 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Utsunomiya","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology, Yokohama City University Graduate School of Medicine , Yokohama, Kanagawa 236-0004 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisuke","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology, Yokohama City University Graduate School of Medicine , Yokohama, Kanagawa 236-0004 , Japan"},{"name":"Department of Radiology, Yuai Clinic Diagnostic Imaging , 1-6-2, Kita-shinyokohama, Kohoku-ku, Yokohama, Kanagawa 223-0059 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinobu","family":"Ishiwata","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology, Yokohama City University Graduate School of Medicine , Yokohama, Kanagawa 236-0004 , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Oka","sequence":"additional","affiliation":[{"name":"Telix Pharmaceuticals Japan K.K. , KRP #4 Building, 93 Chudoji-Awata-machi, Shimogyu-ku, Kyoto-shi, Kyoto , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-6423-9669","authenticated-orcid":false,"given":"Colin","family":"Hayward","sequence":"additional","affiliation":[{"name":"Telix 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