Radiolabeled TSPO Targeted Molecular Probe in AMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction (AMI). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Inflammation Imaging of Acute Myocardial Infarction
Overview
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.
Primary outcome measures
- SUVmax of lesion uptake value [Time frame: Time Frame: 60min after administration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07105982 · KY20250624-07-KS-01