SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease

NCT06326970 | Not Yet Recruiting DMC

• 1 other identifier: HenanICE202401
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myocardial Fibrosis

Outcome Measures

Primary Outcomes (1)

• positive uptake

  99mTc-FAPI accumulation on the heart, measure the standardized uptake values (SUV)

  3 months

Study Arms (1)

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

Interventions

99mTc-FAPI SPECT imaging DIAGNOSTIC_TEST

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.

99mTc-FAPI imaging in heart diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pregnant women
• Severe claustrophobia

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Officials

• Muwei Li, Ph.D.

  Fuwai central China hospital

  PRINCIPAL INVESTIGATOR

• Jing Cui, Ph.D.

  Fuwai central China hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Cui, Ph.D.

CONTACT

+86-0371-58680495; cuijing85@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 22, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share