Clinical trial NCT05543317: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor, Solid
Positron-Emission Tomography
Keywords: Tumor
Solid
Positron-Emission Tomography
diagnosis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Secondary outcomes:
measure: Number of lesions
timeFrame: 30 days
measure: SUV
timeFrame: 7 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Long Sun, PhD
role: STUDY_CHAIR
References: