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NCT Number: NCT07105982

Radiolabeled TSPO Targeted Molecular Probe in AMI

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. SUVmax of lesion uptake value

    Time frame: Time Frame: 60min after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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