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

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07707999
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Novel FAP-targeted probe — DRUG
    For Cancer patients, subjects should have targeting FAP scans

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: PET/SPECT imaging of novel FAP-targeted probe in malignant neoplasm
    This project aims to perform integrated SPECT/CT or PET/MR imaging in patients with histologically confirmed malignant neoplasms with high fibroblast activation protein (FAP) expression. This study utilizes a FAP-specific PET/SPECT imaging probe to evaluate the feasibility, accuracy, and clinical value in malignant neoplasm.

Primary Outcome Measure

Visual and standardized uptake values assessment of lesions and biodistribution [ Time Frame: 1 month ]

Central Contacts

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