68 Ga-BNOTA-PRGD2 PET/CT for evaluation of post-stroke angiogenesis: study protocol for a prospective open-label clinical trial

Background: Arginylglycylaspartic acid (RGD) is a tripeptide composed of L-arginine, glycine, and L-aspartic acid that shows great affinity for the integrin αv β3 receptor. A RGD dimer labeled with 68Ga, 68Ga-BNOTA-PRGD2 was designed for positron-emission tomography/computed tomography (PET/CT) imaging post-stroke angiogenesis, which has rarely been used in the clinic. We aimed to perform a prospective open-label trial to validate the diagnostic value of 68 Ga-BNOTA-PRGD2 PET/CT in post-stroke angiogenesis. Methods/Design: A self-controlled open-label clinical trial will be performed at the PET Center, Department of Nuclear Medicine, Peking Union Medical College Hospital, China. Fifty patients with stroke will undergo 68 Ga-BNOTA-PRGD2 PET/CT, 18 F-FDG PET/CT, and magnetic resonance imaging (MRI) at 2 weeks, 3 months, and 1 year after stroke onset. Primary outcomes include the standardized uptake value (SUV) in the cerebral infarction area and the standardized uptake value ratio of the injured side to the contralateral side detected by 68 Ga-BNOTA-PRGD2 PET/CT. Secondary outcomes include the safety of brain 68 Ga-BNOTA-PRGD2 PET/CT used to evaluate post-stroke angiogenesis. Discussion: Findings from this trial will provide important reference evidence for use of 68 Ga-BNOTA-PRGD2 PET/CT to evaluate post-stroke angiogenesis. Trial registration: ClinicalTrials.gov identifier: NCT01656785; registered on 1 August 2012.