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

NCT05543317 | Completed

• 1 other identifier: 2022KY007
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor, Solid; Positron-Emission Tomography

Keywords

Tumor; Solid; Positron-Emission Tomography; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of lesions

  30 days

• SUV

  7 days

Study Arms (1)

68Ga-FAPI-RGD

EXPERIMENTAL

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

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

Interventions

18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT DIAGNOSTIC_TEST

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.

68Ga-FAPI-RGD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Neoplasms; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Long Sun, PhD

  The First Affiliated Hospital of Xiamen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 27, 2023

Record last verified: 2022-09

Locations

CN (1)