Radiolabeled TSPO Targeted Molecular Probe in AMI

NCT ID: NCT07105982

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-08-31

Brief Summary

Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 for inflammation imaging associated with acute myocardial infarction.

Conditions

Acute Myocardial Infarction (AMI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Volunteers, patients, or their legal representatives must sign the informed consent form and be able to cooperate with the PET-MR examination by lying flat for more than 30 minutes and maintaining a stable position.
• No gender restrictions; age between 18 and 75 years, inclusive.
• Patients must meet the diagnostic criteria for acute myocardial infarction (AMI), such as elevated myocardial enzyme spectrum, dynamic changes in electrocardiogram, or confirmation by coronary angiography.
• Patients who are 7 to 10 days post-onset of acute myocardial infarction.
• Renal GFR > 50 ml/min; ERPF > 280 ml/min; platelet count (PLT) > 75,000/μL; white blood cells (WBC) > 3,000/μL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than three times the upper limit of normal.

Exclusion Criteria

• Individuals with a history of allergy to similar drugs (drugs with similar chemical or biological components to TSPO), a history of allergies, or currently suffering from allergic diseases.
• Use of anti-inflammatory drugs (such as corticosteroids or immunosuppressants) within the last 14 days, which may affect inflammation imaging.
• Hemodynamically unstable conditions (such as cardiogenic shock or severe arrhythmias); Recent cerebral hemorrhage or severe bleeding tendency within the last 30 days.
• Red blood cell count (RBC) < 4×10^12/L, white blood cell count (WBC) < 3×10^9/L, hemoglobin less than 110 g/L, platelet count (PLT) < 75×10^9/L.
• Significant abnormal liver or kidney function, with glomerular filtration rate (GFR) less than 50 ml/min.
• Presence of ferromagnetic metals implanted in the body (such as cardiac pacemakers, artificial heart valves, metal stents, etc.).
• Claustrophobia or inability to tolerate prolonged examinations.
• Presence of severe acute concomitant diseases or severe refractory mental disorders.
• Pregnant or breastfeeding women (pregnancy defined as a positive urine pregnancy test).
• Patients whose physical condition contraindicates radioactive examinations, such as severe cardiopulmonary insufficiency or other conditions deemed unsuitable by the investigator.
• Other circumstances deemed unsuitable for participation in the trial by the researcher.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Feng Wang

Role: CONTACT

fengwangcn@hotmail.com

+8602552271491

Other Identifiers

KY20250624-07-KS-01

Identifier Type: -

Identifier Source: org_study_id