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NCT06326970 Clinical Trial

SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease

Myocardial Fibrosis Clinical Trial

Official title:
SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06326970
Other study ID # HenanICE202401
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date March 2025

Study information
Verified date March 2024
Source Henan Institute of Cardiovascular Epidemiology
Contact Jing Cui, Ph.D.
Phone +86-0371-58680495
Email cuijing85@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis or suspected of cardiac injury - Must be able to receive PET/CT scan Exclusion Criteria: - Pregnant women - Severe claustrophobia

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Henan Institute of Cardiovascular Epidemiology

Outcome
Type Measure Description Time frame Safety issue
Primary positive uptake 99mTc-FAPI accumulation on the heart, measure the standardized uptake values (SUV) 3 months
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