68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG

Tumor, Solid Clinical Trial

Official title:

68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05543317
• Other study ID #: 2022KY007
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: The First Affiliated Hospital of Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.

Description:

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• adult patients (aged 18 years or order);

• patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);

• patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD 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.

Related Conditions & MeSH terms

• Positron-Emission Tomography
• Tumor, Solid

Intervention

Diagnostic Test:
• 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-RGD, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficacy	The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-RGD PET/CT were calculated and compared to evaluate the diagnostic accuracy.	30 days
Secondary	Number of lesions	The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation.	30 days
Secondary	SUV	Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-RGD PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.	7 days