- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533828
68Ga-FAPI PET/CT in Liver Fibrosis Patients (GFAPILF)
September 2, 2020 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis
To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis and prognosis in liver fibrosis disease.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Subjects with liver fibrosis underwent 68Ga-FAPI-04 PET/CT scanning.
Liver fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax).
Subjects also received the conventional clinical assessment for liver fibrosis, such as transient elastography (TE) 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, TE and BBI were calculated and compared to evaluate the diagnostic efficacy.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weibing Miao, M.D.
- Phone Number: 86-591-87981618
- Email: miaoweibing@126.com
Study Contact Backup
- Name: Chao Huang
- Phone Number: 86-591-87981619
- Email: huangc1987@163.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Recruiting
- The First Affiliated Hospital of Fujian Medical University
-
Contact:
- Weibing Miao, M.D.
- Phone Number: 86-591-87981618
- Email: miaoweibing@126.com
-
Contact:
- Chao Huang
- Phone Number: 86-591-87981619
- Email: huangc1987@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients (aged 18 years or order)
- patients with suspected or new diagnosed or previously treated liver fibrosis (supporting evidence may include TE, 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 without liver fibrosis lesions
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 68Ga-FAPI-04 PET/CT scanning
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
|
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized uptake value (SUV)
Time Frame: 30 days
|
Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver stiffness measurement (LSM)
Time Frame: 30 days
|
Liver stiffness measurement (LSM) of transient elastography (TE) for each subject.
|
30 days
|
Blood biochemical indexes (BBI) testing
Time Frame: 30 days
|
APRI (Aspartate aminotransferase to Platelet Ratio Index) and FIB-4 (Fibrosis-4) were calculated through blood biochemical indexes (BBI) testing for each subject. APRI = (AST)/(PLT)×100, FIB-4 = (Age×AST)/(PLT)×(ALT )^(1/2). ALT (Alanine transaminase), AST (Aspartate transaminase) and PLT (Platelets) counts were obtained from BBI testing. |
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2020
Primary Completion (ANTICIPATED)
August 31, 2023
Study Completion (ANTICIPATED)
December 30, 2023
Study Registration Dates
First Submitted
August 22, 2020
First Submitted That Met QC Criteria
August 29, 2020
First Posted (ACTUAL)
September 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 3, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAPILF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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