18F-FAPI-RGD PET/CT in Various Tumor Types

Recruiting

• Conditions: Neoplasms

• Registration Number: NCT06094530
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.

Detailed Description

The aim of this study is to evaluate, in patients with various types of tumor, the radiotracer uptake and clinical feasibility of 18F-FAPI-RGD PET/CT compared with those of 18F-FDG PET/CT. To evaluate the diagnostic performance of 18F-FAPI-RGD and 18F-FDG PET imaging, the results of the visually interpreted PET images will be compared with the histopathologic results (via surgery or biopsy), which are used as the gold standard for the final diagnosis. For patients for whom tissue diagnosis is not applicable, clinical and radiographic follow-up data will be used as the reference standard to validate the PET/CT findings.

Study Timeline

• Study Start: 2023-04-10
• Status Verified: 2023-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with clinically suspected or diagnosed tumors

Exclusion Criteria

• Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
• Complicated with chronic liver disease, myocardial infarction, stroke
• Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
• Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors	1 month	Tracer uptake in normal organs (background) is quantified by SUVmean, which is delineated with a sphere that had a diameter of 1 cm (for small organs, including thyroid, salivary gland, and pancreas) to 2 cm(for other organs, including brain, heart, liver, kidney, spleen, muscle, and bone marrow) placed inside the organ parenchyma. The tumor-to background ratio (TBR) is calculated as tumor SUVmax/background SUVmean.

Trial Locations

Locations (1)

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China