Visualized Monitoring of Fibrosis Formation in Heart Failure With 68GA-FAPI PET

October 8, 2022 updated by: Xiaoli Lan, Wuhan Union Hospital, China

Clinical Study of 68 GA-FAPI PET Imaging Noninvasive Visible Fibrosis Formation in Heart Failure

This is a diagnostic study. Patients were included from patients with clinically suspected or confirmed heart failure, and 68Ga-FAPI and 13N-NH3 gated myocardial imaging were performed to evaluate the effectiveness of 68Ga-FAPI PET imaging in visualizing the degree of myocardial fibrosis in patients with heart failure. The subjects completed 68Ga-FAPI and 13N-NH3 gated myocardial imaging in a one-stop process, and collected general information, clinical data, echocardiography, blood routine, liver and kidney function indicators, 68Ga-FAPI and 13N-NH3 PET imaging results and other imaging data of the patients and volunteers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Fibroblast activated protein (FAP) is a type II membrane-bound glycoprotein that is highly specifically expressed in activated fibroblast reactions. The 68Ga labeled fibroblast activated protein inhibitor (68 ga-fapi) has shown advantages of high uptake and high image contrast in imaging the activated fibroblast response, including its successful use in visualizing the degree of liver fibrosis. The molecular imaging probe targeting FAP combined with the mature myocardial perfusion imaging agent 13N-NH3 can help us to achieve the following objectives: On the one hand, to investigate the myocardial fibrosis in patients with heart failure and to visualize the formation of fiBER-activated protein in the process of heart failure; At the same time, the performance of 68GA-FAPI in differential diagnosis of heart failure and grading of heart failure degree was discussed, so as to make up for the insufficiency of clinical routine imaging technology in the diagnosis of myocardial fibrosis in heart failure.

Study Type

Observational

Enrollment (Anticipated)

50

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Xiaoli Lan

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with clinically suspected or confirmed heart failure (supporting evidence including visual examination, cardiac MRI, cardiac ultrasound, and serological indicators, etc.), and who have consenting to 68GA-FAPI and 13N-NH3 imaging;

Description

Inclusion Criteria:

  • Adult patients (age 18 years or above), gender is not limited;
  • Patients with clinically suspected or confirmed heart failure (supporting evidence includes visual examination, cardiac MRI, cardiac ultrasound, and serological indicators, etc.), and patients who agree to undergo 68Ga-FAPI and 13N-NH3 imaging;
  • The patient or his legal representative can sign the informed consent.

Exclusion Criteria:

  • Acute systemic diseases and electrolyte disorders；
  • Pregnant or lactating women；
  • Patients refuse to sign the 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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of 68Ga-FAPI PET for diagnosis and staging in heart failure.
Time Frame: 2 years
For 50 subjects with suspected or diagnosed or treated heart failure who have completed 13N-NH3 imaging, diagnosis and staging results of 68Ga-FAPI PET will be compared to pathology, clinical and follow-up result.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XLan-0617-01

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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