Clinical Trial

Clinical Application of FAP-Targeted Radionuclide Imaging in the Diagnosis and Staging of Malignant Solid Tumors

Not Yet Recruiting Early Phase 1
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Summary
This study is a single-center, open-label first-in-human clinical study. Patients with clinically suspected or confirmed malignant solid tumors will undergo \[68Ga\]Ga-FAP PET imaging or \[177Lu\]Lu-FAP SPECT imaging as well as \[18F\]FDG PET imaging to determine the presence or absence of lesions, and to assess lesion location, characteristics, and metastasis. Histopathological diagnosis or follow-up results will serve as the reference standard. The diagnostic efficacy of \[68Ga\]Ga-FAP PET imaging or \[177Lu\]Lu-FAP SPECT imaging for malignant tumors will be evaluated. Additionally, the study will analyze the biodistribution and dosimetry of \[177Lu\]Lu-FAP following a single administration, explore the correlation between tumor uptake values on imaging and immunohistochemical FAP expression levels, and evaluate the safety and tolerability of a single low-dose intravenous injection of \[68Ga\]Ga-FAP or \[177Lu\]Lu-FAP for diagnostic imaging.
Trial Details
NCT Number NCT07707999
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Malignant Neoplasm
Enrollment 20 participants
Start Date 2026-07-30
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16