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

The First Affiliated Hospital of Xiamen University27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Tumor, Solid Positron-Emission Tomography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 30 days

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.

Time frame: 7 days