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

Cancer Clinical Trial

— FAPI-VTC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05485792
• Other study ID #: FAPI-malignancy
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2022
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: Rusen Zhang, MD
• Phone: 0086-13642328295
• Email: zhangrusen2015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Diagnostic Test:
• 18F-FAPI PET/CT and 18F-FDG PET/CT
Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum standardized uptake value (SUVmax)	The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT	30 days
Secondary	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