ClinicalTrials.Veeva

Menu

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

Xiamen University logo

Xiamen University

Status

Completed

Conditions

Tumor, Solid
Positron-Emission Tomography

Treatments

Diagnostic Test: 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05543317
2022KY007

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

68Ga-FAPI-RGD
Experimental group
Description:
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAPI-RGD, and undergo PET/CT imaging within the specified time.
Treatment:
Diagnostic Test: 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems