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NCT04831034 Clinical Trial

68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

Fibrosis Clinical Trial

Official title:
68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04831034
Other study ID # FirstAHFujian7
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date April 1, 2021
Est. completion date April 1, 2024

Study information
Verified date September 2023
Source First Affiliated Hospital of Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease

Description:

Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - adult patients (aged 18 years or order) - patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report) - patients who had scheduled 68Ga-FAPI-04 PET/CT scan - 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 pregnancy - the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Ga-FAPI-04
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Locations
Country Name City State
China Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Standardized uptake value (SUV) Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject. 30 days
Secondary Diagnostic efficacy The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated. 30 days
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