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

Sponsor
First Affiliated Hospital of Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04831034
Collaborator
(none)
500
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
13.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. Standardized uptake value (SUV) [30 days]

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

Secondary Outcome Measures

  1. Diagnostic efficacy [30 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005

Sponsors and Collaborators

  • First Affiliated Hospital of Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibing Miao, PhD, Director, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier:
NCT04831034
Other Study ID Numbers:
  • FirstAHFujian7
First Posted:
Apr 5, 2021
Last Update Posted:
Apr 5, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fibrosis

Study Results

No Results Posted as of Apr 5, 2021