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68Ga-FAPI PET/CT in Liver Fibrosis Patients (GFAPILF)

Primary Purpose

Liver Fibrosis, Positron Emission Tomography

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI-04
Sponsored by
First Affiliated Hospital of Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI-04 PET/CT scanning

Arm Description

Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Outcomes

Primary Outcome Measures

Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.

Secondary Outcome Measures

Liver stiffness measurement (LSM)
Liver stiffness measurement (LSM) of transient elastography (TE) for each subject.
Blood biochemical indexes (BBI) testing
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.

Full Information

First Posted
August 22, 2020
Last Updated
September 2, 2020
Sponsor
First Affiliated Hospital of Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04533828
Brief Title
68Ga-FAPI PET/CT in Liver Fibrosis Patients
Acronym
GFAPILF
Official Title
Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Positron Emission Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-FAPI-04 PET/CT scanning
Arm Type
Experimental
Arm Description
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI-04
Intervention Description
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
Primary Outcome Measure Information:
Title
Standardized uptake value (SUV)
Description
Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Liver stiffness measurement (LSM)
Description
Liver stiffness measurement (LSM) of transient elastography (TE) for each subject.
Time Frame
30 days
Title
Blood biochemical indexes (BBI) testing
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weibing Miao, M.D.
Phone
86-591-87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Huang
Phone
86-591-87981619
Email
huangc1987@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibing Miao, M.D.
Phone
86-591-87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name & Degree
Chao Huang
Phone
86-591-87981619
Email
huangc1987@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

68Ga-FAPI PET/CT in Liver Fibrosis Patients

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