68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Myocardial Infarction (GRGDMI)
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|ClinicalTrials.gov Identifier: NCT01542073|
Recruitment Status : Unknown
Verified November 2014 by gwcmc.
Recruitment status was: Recruiting
First Posted : March 1, 2012
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: 68Ga-BNOTA-PRGD2||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Angiogenesis of Myocardial Infarction and the Comparison With Cardiac Perfusion and Metabolism|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: 68Ga-BNOTA-PRGD2 cardiac PET/CT scanning
We will perform 68Ga-BNOTA-PRGD2 cardiac PET/CT scanning on myocardial infarction patients to determine its value.
Intravenous injection of one dosage of 111 MBq 68Ga-BNOTA-PRGD2. Tracer doses of 68Ga-BNOTA-PRGD2 will be used to image angiogenesis of myocardial infarction area by positron emission tomography / computed tomography (PET/CT)
Other Name: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2
- Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of myocardial infarction region and normal left ventricular wall [ Time Frame: 1 year ]Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician and will compare to 99mTc-MIBI myocardial perfusion imaging and 18F-FDG myocardial metabolism imaging obtained within a week. The semiquantitative analysis will be performed by the same person for all the cases, and the MI region standardized uptake values (SUVs), the SUV ratios (SUV of MI/SUV normal LV), and other organs' SUVs will be measured.
- Number of participants with adverse events [ Time Frame: 1 year ]Adverse events within 5 days after 68Ga-BNOTA-PRGD2 injection and PET/CT scanning of the patients will be collected and assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542073
|Contact: Zhaohui Zhu, MDemail@example.com|
|Department of Nuclear Medicine, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD 86-10-13611093752 firstname.lastname@example.org|
|Contact: Chenxi Wu, MD 86-10-15911068700 email@example.com|
|Principal Investigator:||Zhaohui Zhu, MD||Department of Nuclear Medicine, Peking Union Medical College Hospital|