Coronary Artery Disease Clinical Trial
Official title:
68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Angiogenesis of Myocardial Infarction and the Comparison With Cardiac Perfusion and Metabolism
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.
Integrin αvβ3 is an important member of integrin receptor family and expressed
preferentially on regenerative vascular endothelial cells and some tumor cells, but not or
very low expressed on the quiescent vessel cells and other normal cells. The αvβ3 integrin
is a key mediator of angiogenesis and thus may be an important diagnostic and therapeutic
target associated with myocardial repair processes after ischaemic injury.
The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to
the integrin αvβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have
been developed for non-invasive imaging of integrin αvβ3 expression via positron emission
tomography (PET) or single photon emission computed tomography (SPECT). Among all the RGD
radiotracers studied in Myocardial Infarction (MI), 18F-Galacto-RGD and 99mTc-RGD has been
investigated clinically in acute MI patients, showing focal tracer retention localized in
the infarcted area. Recently, series of RGD dimeric peptides with PEG linkers have been
developed. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding
affinity than the single RGD tri-peptide sequence. As a representative, 68Ga-BNOTA-PRGD2
could be easily prepared and exhibited excellent in vivo behaviors in animal models. No
adverse reactions are observed in both animal and human studies to date.
For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, a open-label PET/CT
study was designed to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in
myocardial infarction patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg
BNOTA-PRGD2) will be intravenously injected into the myocardial infarction patients. Visual
and semiquantitative method will be used to assess the PET/CT images. 99mTc-MIBI myocardial
perfusion SPECT images and 18F-FDG metabolism images will be used for co-registrated
comparison.
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