Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT

Not Applicable

• Conditions: Pancreatic Cancer; Gastric Cancer; Liver Cancer
• Interventions: Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CT

• Registration Number: NCT05430841
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.

Detailed Description

Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI 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 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-01
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Last Update Submitted: 2022-06-20
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• adult patients (aged 18 years or order);
• patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
• patients who had scheduled both 18F-FDG and 18F-AlF-FAPI 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
18F-AlF-FAPI PET/CT	18F-FDG, 18F-AlF-FAPI PET/CT	Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	30 days	The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Secondary Outcome Measures

Name	Time	Method
SUV	7 days	Standardized uptake value (SUV) of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Number of lesions	7 days	The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.

Trial Locations

Locations (1)

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