68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Stroke (GRGDS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01656785|
Recruitment Status : Unknown
Verified November 2014 by gwcmc.
Recruitment status was: Recruiting
First Posted : August 3, 2012
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: 68Ga-BNOTA-PRGD2||Early Phase 1|
Integrin αvβ3 is an important member of this receptor family and expressed preferentially on regenerative vascular endothelial cells, but not or very low 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 cerebrovascular repair processes after stroke.
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) to monitor the angiogenesis in clinical Oncology and Cardiology. In Neurology, angiogenesis imaging based on integrin αvβ3 receptor has not been found in clinical trials, but preclinical animal studies showed it had great potential for clinical translation. Recently, series of RGD dimeric peptides with PEG linkers have been studied. 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 behavior in animal models and also tumor or myocardial infarction patients. No adverse reactions are observed in animal models or patients to date.
For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, an open-label brain PET/CT study was designed to investigate diagnostic performance of 68Ga-BNOTA-PRGD2 in stroke patients in convalescence. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of brain 18F-FDG PET/CT, enhanced brain MRI or CT, and any adverse events will be collected from the patients.
|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 Following Stroke|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Brain 68Ga-BNOTA-PRGD2
We will perform brain 68Ga-BNOTA-PRGD2 PET/CT on stroke patients to determine its value.
Intravenous injection of one dosage of 111MBq 68Ga-BNOTA-PRGD2 solution. Tracer doses of 68Ga-BNOTA-PRGD2 will be used to image angiogenesis of cerebral infarction areas 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 cerebral infarction region, SUV ratios (SUVinfarction/SUV contralateral) [ Time Frame: 1 year ]Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physicians. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of suspicious region in the stroke area and the SUV ratios (SUVinfarction/SUV contralateral) will be measured.
- Adverse events collection [ Time Frame: 1 year ]Adverse events within 5 days after the injection and PET/CT scanning 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): NCT01656785
|Contact: Zhaohui Zhu, MD, PhDfirstname.lastname@example.org|
|Department of Nuclear Medicine, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD, PhD 86-10-13611093752 email@example.com|
|Contact: Chenxi Wu, MD 86-10-15911068700 firstname.lastname@example.org|
|Principal Investigator:||Zhaohui Zhu, MD, PhD||Department of Nuclear Medicine, Peking Union Medical College Hospital|