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Trial Title: 18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer

NCT ID: NCT05485792

Condition: Cancer

Conditions: Official terms:
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Subjects with various types of cancer undergo contemporaneous 18F-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: 18F-FAPI PET/CT and 18F-FDG PET/CT
Description: Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week
Arm group label: 18F-FAPI PET/CT

Summary: FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

Detailed description: Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for the visualization of CAFs. CAFs are crucial component of tumor stroma, promote the growth of cancer cells and are associated with poor prognosis. Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors, including lung cancer, gastric carcinomas, peritoneal carcinomas. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. adult patients (aged 18 years or order); 2. patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report); 3. patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans; 4. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: 1. patients with non-malignant lesions; 2. patients with pregnancy; 3. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Start date: August 1, 2022

Completion date: December 30, 2023

Lead sponsor:
Agency: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class: Other

Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05485792

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