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68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

Primary Purpose

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 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 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

Sites / Locations

  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI-04

Arm Description

Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.

Outcomes

Primary Outcome Measures

Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject.

Secondary Outcome Measures

Diagnostic efficacy
The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Full Information

First Posted
April 1, 2021
Last Updated
September 15, 2023
Sponsor
First Affiliated Hospital of Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04831034
Brief Title
68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease
Official Title
68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (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 fibrotic disease
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-FAPI-04
Arm Type
Experimental
Arm Description
Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed 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-DOTA/NOTA-FAPI-04 for each target lesion of subject.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Diagnostic efficacy
Description
The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
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 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
Facility Information:
Facility Name
Department of Nuclear Medicine, 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, MD
Phone
+86 591 87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name & Degree
Kaixian Lin, MD
Phone
+86 591 87981619
Email
kaysonlin@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

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