Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer

Not Applicable

Completed

• Conditions: Tumor, Solid; Positron-Emission Tomography
• Interventions: Diagnostic Test: 18F-FDG

• Registration Number: NCT05392205
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the potential usefulness of 68Ga-FAP-2286 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

Subjects with various types of cancer underwent contemporaneous 68Ga-FAP-2286 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-FAP-2286 PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 68Ga-FAP-2286, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-22
• Study First Posted: 2022-05-26
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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-FAP-2286 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAP-2286	18F-FDG	Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-2286, and undergo PET/CT imaging within the specified time.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	90 days	The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAP-2286 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Secondary Outcome Measures

Name	Time	Method
Number of lesions	90 days	The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAP-2286 PET/CT were recorded by visual interpretation.
Standardized uptake value (SUV)	30 days	Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAP-2286 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Trial Locations

Locations (1)

The First affiliated hospital of xiamen university; 🇨🇳 Xiamen, Fujian, China