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68Ga-SorB PET/CT Imaging in Patients With Solid Tumors

Sponsor: Peking University Third Hospital • ClinicalTrials.gov ID: NCT07760012

Registry updated: 2026-10-15

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Description

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.

Interventions

68Ga-SorB PET/CT (Diagnostic test)
Participants will receive a single intravenous administration of 68Ga-SorB (approximately 3.7 MBq/kg), followed by whole-body PET/CT imaging approximately 60 minutes after injection. The imaging findings will be compared with clinically indicated 18F-FDG PET/CT and reference standard findings to evaluate the safety, feasibility, biodistribution, tumor uptake, and exploratory diagnostic performance of 68Ga-SorB PET/CT.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 or older. * Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, ovarian cancer, or cholangiocarcinoma. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, renal, and coagulation function: * White blood cell count ≥ 4.0 × 10\^9/L or absolute neutrophil count ≥ 1.5 × 10\^9/L; * Platelet count ≥ 100 × 10\^9/L; * Hemoglobin ≥ 90 g/L; * PT or APTT ≤ 1.5 × upper limit of normal (ULN); * Total bilirubin ≤ 1.5 × ULN; * ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for participants with liver metastases); * ALP ≤ 2.5 × ULN (or ≤ 4.5 × ULN for participants with bone or liver metastases); * Blood urea nitrogen and serum creatinine ≤ 1.5 × ULN. * Normal cardiac function. * Estimated life expectancy of at least 12 weeks. * Willing and able to comply with study procedures and follow-up. * At least one measurable target lesion according to RECIST version 1.1. * Participants of childbearing potential agree to use effective contraception during the study and for 3 months after PET/CT imaging. * Clinically indicated to undergo 18F-FDG PET/CT for tumor evaluation. * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Pregnant or breastfeeding women. * Severe dysfunction of major organs (including heart, liver, or kidney) that, in the investigator's judgment, would make participation inappropriate. * Inability to tolerate PET/CT imaging or complete study follow-up. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Conditions

Melanoma (Skin Cancer) Hepatocellular Carcinoma Lung Cancer Breast Cancer Pancreatic Cancer Ovarian Cancer Cholangiocarcinoma

Locations

Peking University Third Hospital — Beijing, Beijing Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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