Radiolabeled TSPO Targeted Molecular Probe in AMI

NCT07105982 | Not Yet Recruiting

• 1 other identifier: KY20250624-07-KS-01
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• SUVmax of lesion uptake value

  Time Frame: 60min after administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were recruited through hospital electronic records and community health centers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Central Study Contacts

Feng Wang

CONTACT

+8602552271491; fengwangcn@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07