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68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors
Sponsor: Peking University Cancer Hospital & Institute
Summary
This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection. In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.
Official title: Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET/CT for the Diagnosis and Staging of Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-06
Completion Date
2026-12-31
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
68Ga-FAPI-PSMA
Participants will receive an intravenous injection of the investigational PET tracer 68Ga-FAPI-PSMA (0.1-0.15 mCi/kg). Whole-body PET/CT imaging will be performed approximately 1 hour after injection. Delayed imaging at 2-4 hours may be performed when necessary. Imaging results will be used to evaluate tracer uptake in tumor lesions and to assess the diagnostic performance of the dual-targeted tracer.
68Ga-PSMA-617
Participants will receive an intravenous injection of the PET tracer 68Ga-PSMA-617 (0.1-0.15 mCi/kg) followed by PET/CT imaging approximately 1 hour after administration. This imaging serves as a comparator to evaluate the diagnostic performance of the investigational tracer 68Ga-FAPI-PSMA.
68Ga-FAPI-04
Participants may undergo PET/CT imaging using the PET tracer 68Ga-FAPI-04 (0.1-0.15 mCi/kg) with imaging performed approximately 1 hour after injection. This imaging will serve as a comparator for assessing the diagnostic performance of 68Ga-FAPI-PSMA PET/CT.