68Ga-FAPI PET/CT in Liver Fibrosis Patients
GFAPILF
Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2020
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedSeptember 3, 2020
September 1, 2020
3 years
August 22, 2020
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.
30 days
Secondary Outcomes (2)
Liver stiffness measurement (LSM)
30 days
Blood biochemical indexes (BBI) testing
30 days
Study Arms (1)
68Ga-FAPI-04 PET/CT scanning
EXPERIMENTALEach subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
Interventions
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Nuclear Medicine
Study Record Dates
First Submitted
August 22, 2020
First Posted
September 1, 2020
Study Start
September 1, 2020
Primary Completion
August 31, 2023
Study Completion
December 30, 2023
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share