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

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:

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.
Drug: 68Ga-FAPI-04
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.

Sponsor

First Affiliated Hospital of Fujian Medical University

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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