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Clinical Trials/NCT06688071
NCT06688071
Recruiting
Not Applicable

FAPI PET/CT in Various FAP-Related Disease Patients

Tianjin Medical University1 site in 1 country500 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
FAP-related Disease
Sponsor
Tianjin Medical University
Enrollment
500
Locations
1
Primary Endpoint
Standardized uptake value (SUV)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

To evaluate the potential usefulness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various FAP-related disease patients.

Detailed Description

Subjects with various FAP-related disease patients underwent 68Ga/18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-FAPI PET/CT were calculated.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
October 1, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Tianjin Medical University
Responsible Party
Principal Investigator
Principal Investigator

Shaobo Yao, PhD

Prof.

Tianjin Medical University General Hospital

Eligibility Criteria

Inclusion Criteria

  • (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 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

  • (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Outcomes

Primary Outcomes

Standardized uptake value (SUV)

Time Frame: 30 days

Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary Outcomes

  • Diagnostic efficacy(30 days)

Study Sites (1)

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