18F-FAPI PET/CT in Patients With Various Types of Cancer

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Drug: 18F-FAPI

• Registration Number: NCT05810324
• Lead Sponsor: Jilin University

Brief Summary

To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed Description

Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-07-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
• patients who had scheduled 18F-FAPI PET/CT scan; (iv)
• 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-FAPI	18F-FAPI	Experimental: Experimental: 18F-FAPI Each subject receive a single intravenous injection of 18F-FAPI, and undergo PET/CT imaging within the specificed time.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	1 year	The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.

Trial Locations

Locations (1)

China-Japan Union Hospital; 🇨🇳 Chang chun, Jilin, China