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Radiolabeled TSPO Targeted Molecular Probe in AMI

Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Inflammation Imaging of Acute Myocardial Infarction

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07105982
Enrollment
8
Registered
2025-08-06
Start date
2025-09-01
Completion date
2026-08-31
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction (AMI)

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.

Interventions

None listed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
SUVmax of lesion uptake valueTime Frame: 60min after administration

Contacts

Primary ContactFeng Wang
fengwangcn@hotmail.com+8602552271491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026