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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study on Comparison 18F-FAPI and 18F-FDG PET/CT in the Evaluation of Patients With Various Types of Cancer

Conditions
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Cancer

Intervention / Treatment
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* Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (aged 18 years or order); patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report); patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans; 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: patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FAPI PET/CT<br>Each subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week | Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT<br>* Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum standardized uptake value (SUVmax) | The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The target-to-background ratio (TBR) | The target-to-background ratio (TBR) was calculated by dividing the SUVmax of the lesion by the SUVmax of soft tissue background | 30 days |