Clinical Research on 68Ga-FAPI PET/CMR in Cardiovascular Diseases

NCT07063043 | Recruiting DMC

• 1 other identifier: 2025YS-039
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

FAP-targeted PET imaging using 68Ga-FAPI enables early detection of myocardial fibrosis. Combined PET/CMR provides comprehensive cardiac assessment without extra radiation. This advanced imaging approach improves diagnosis and personalized treatment for better patient outcomes.

Conditions

Cardiovascular Diseases (CVD)

Keywords

Cardiovascular diseases; FAPI; PET/MR

Outcome Measures

Primary Outcomes (3)

• CE-CMR

  Left ventricular wall thickness was quantified on short-axis cine images using the MR cardiac analysis software .

  After the patient completes the scan, an average of 2 days.

• CE-MRI

  Left ventricular ejection fraction (LVEF) was calculated from short-axis cine images using the cardiac MR analysis software.

  After the patient completes the scan, an average of 2 days.

• PET

  The maximum standardized uptake value (SUVmax) was calculated for each myocardial segment.

  After the patient completes the scan, an average of 2 days.

Study Arms (2)

Research group

Thirty patients with cardiovascular diseases were enrolled as the research group.

Healthy controls

Ten healthy individuals were enrolled as the healthy controls.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular diseases

You may qualify if:

• Participants must have a confirmed clinical diagnosis of cardiovascular disease by a cardiologist, based on genetic testing, family history, and comprehensive clinical evaluation including physical examination, echocardiography, and when indicated, cardiac MRI findings.
• Age requirement: \>18 years.
• Patients should demonstrate stable cardiovascular status without significant changes in symptoms, treatment, or clinical findings for a specified pre-enrollment period.
• Participants must be capable of providing informed consent and willing to adhere to all study requirements, including follow-up procedures.

You may not qualify if:

• History of malignancy
• Documented cardiovascular diseases, including coronary artery disease, myocardial infarction, or related conditions
• Implanted metallic devices (e.g., pacemakers, aneurysm clips) or other MRI-incompatible medical prostheses
• Claustrophobia
• Pregnancy or lactation
• Known hypersensitivity to gadolinium-based contrast agents
• Renal impairment (eGFR \<30 mL/min/1.73m² by CKD-EPI equation)

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Jie Ding, MD

CONTACT

086-38804518; dingjie940406@163.com

Study Design

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

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)