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Life sciences · Interventional Study
ClinicalTrials.gov · October 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07760012). This is a study registration, not published results. Lead sponsor: Peking University Third Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Melanoma (Skin Cancer), Hepatocellular Carcinoma, Lung Cancer, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Cholangiocarcinoma. Interventions: DIAGNOSTIC_TEST: 68Ga-SorB PET/CT. Primary outcome measures: Incidence of adverse events related to 68Ga-SorB PET/CT , From tracer administration until completion of the imaging visit (approximately 24 hours).; Successful completion of 68Ga-SorB PET/CT imaging , At completion of PET/CT imaging (approximately 60 minutes after tracer injection); Tumor uptake of 68Ga-SorB measured by SUVmax , At PET/CT imaging (approximately 60 minutes after tracer injection). Brief summary: This prospective, single-center, open-label exploratory diagnostic study aims to evaluate the safety, feasibility, and diagnostic performance of the novel Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Eligible participants with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, ovarian cancer, or cholangiocarcinoma will undergo 68Ga-SorB PET/CT imaging. The imaging findings will be compared with standard-of-care 18F-FDG PET/CT, using pathology results and/or clinical follow-up as the reference standard. The primary objectives are to evaluate the safety and tolerability of 68Ga-SorB, assess imaging feasibility, and characterize tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR). Secondary exploratory objectives include comparing lesion detection between 68Ga-SorB PET/CT and 18F-FDG PET/CT, assessing diagnostic sensitivity and specificity, evaluating imaging characteristics across different tumor types, and exploring the correlation between Sortilin expression and tracer uptake. This study will provide preliminary clinical evidence supporting the development of Sortilin-targeted molecular imaging and future theranostic applications.