Viewing Study NCT04831034


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Study NCT ID: NCT04831034
Status: UNKNOWN
Last Update Posted: 2023-09-21
First Post: 2021-04-01
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: 68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease
Sponsor: First Affiliated Hospital of Fujian Medical University
Organization:

Study Overview

Official Title: 68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease
Status: UNKNOWN
Status Verified Date: 2023-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: