- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04831034
68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease
September 15, 2023 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease
To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
500
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 Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Recruiting
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
-
Contact:
- Weibing Miao, MD
- Phone Number: +86 591 87981618
- Email: miaoweibing@126.com
-
Contact:
- Kaixian Lin, MD
- Phone Number: +86 591 87981619
- Email: kaysonlin@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
Description
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 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 68Ga-FAPI-04
Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed 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-DOTA/NOTA-FAPI-04 for each target lesion of subject.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic efficacy
Time Frame: 30 days
|
The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
|
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 (Actual)
April 1, 2021
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
April 1, 2021
First Submitted That Met QC Criteria
April 1, 2021
First Posted (Actual)
April 5, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FirstAHFujian7
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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