SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease

March 21, 2024 updated by: Henan Institute of Cardiovascular Epidemiology

This observational study aims to learn about the preliminary exploration of 99mTc-FAPI imaging in heart diseases and its potential application.

Participant involves patients with myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors, health conditions may also studied as control.

The main questions it aims to answer are 1, radionuclide 99mTc labeled fibroblast-activated protein inhibitors (99mTc-FAPI) imaging in the use of cardiac diseases and its limitations. 2, the performance in subjects with different control of hypertension to evaluate myocardial injury and fibrosis for providing a molecular biological basis for the study of diseases and mechanisms.

Participants will undergo 99mTc-FAPI imaging by Single-photon emission computed tomography (SPECT) and record their cardiac disease characterization and treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with suspected or confirmed myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors.

Description

Inclusion Criteria:

  • Clinical diagnosis or suspected of cardiac injury
  • Must be able to receive PET/CT scan

Exclusion Criteria:

  • Pregnant women
  • Severe claustrophobia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
99mTc-FAPI imaging in heart diseases
Participant involves patients with myocarditis, hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors.
Diagnostic test: 99mTc-FAPI SPECT imaging
99mTc radionuclide is labeled to a HYINC-FAPI-04 probe as a tracer. SPECT imaging was performed 2 hours after 99mTc-FAPI intravenous injection into the subject, and image processing and quantitative analysis were performed using the Q.Volumetrix MI System software package.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive uptake
Time Frame: 3 months
99mTc-FAPI accumulation on the heart, measure the standardized uptake values (SUV)
3 months

Collaborators and Investigators

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

Sponsor

Henan Institute of Cardiovascular Epidemiology

Investigators

  • Principal Investigator: Muwei Li, Ph.D., Fuwai central China hospital
  • Principal Investigator: Jing Cui, Ph.D., Fuwai central China hospital

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanICE202401

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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