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

Neoplasms Clinical Trial

Official title:

Clinical Evaluation of 18F-FAPI-RGD PET/CT for Imaging of Fibroblast Activation Protein and Integrin avb3 in Various Tumor Types

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094530
• Other study ID #: SichuanPPH-cancers
• Status: Recruiting
• Start date: April 10, 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Sichuan Provincial People's Hospital
• Contact: Hao Wang, Doctor
• Phone: +86-18313820216
• Email: 474556259[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Locations

Country	Name	City	State
China	Departments of Nuclear Medicine, Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors	Tracer uptake in normal organs (background) is quanti?ed 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.	1 month