68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Myocardial Infarction

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label PET/CT (positron emission tomography/computed tomography) study to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of myocardial infarction. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into myocardial infarction patients. Visual and semiquantitative method will be used to assess the 68Ga-BNOTA-PRGD2 PET/CT cardiac images and compared to the 99mTc-MIBI SPECT myocardial perfusion images and the 18F-FDG metabolism images.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

Criteria

Inclusion Criteria:

Myocardial infarction patients:

• Males and females

• ≥30 years old

• Patients had myocardial infarction diagnosis (fulfilling two or three symptoms:

clinical history of ischaemic type chest pain lasting for more than 20 minutes, changes in serial ECG tracings, rise and fall of serum cardiac biomarkers such as creatine kinase-MB fraction and troponin)

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential

• Have other kinds of heart diseases

• Renal function: serum creatinine >3.0 mg/dL (270 μM/L)

• Liver function: any hepatic enzyme level more than 5 times upper limit of normal.

• Known severe allergy or hypersensitivity to IV radiographic contrast.

• Patients not able to enter the bore of the PET/CT scanner.

• Inability to lie still for the entire imaging time because of cough, pain, etc.

• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.