Diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) positron emission tomography/computed tomography in patients with brain gliomas: study protocol for an open-label single-arm clinical trial

Abstract

Background: Gastrin-releasing peptide receptor is particularly expressed in gliomas, while the peptide bombesin [BBN(7-14)] has the complete C-terminal structure of human gastrin-releasing peptide. Glioma-specific imaging agents can therefore be constructed from BBN, for example 68Ga-NOTA-Aca-BBN(7-14). For consideration of the clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body positron emission tomography/computed tomography (PET/CT) study was designed to investigate the diagnostic effectiveness and safety of 68Ga-NOTA-Aca-BBN(7-14) in patients with brain gliomas. Methods/Design: This is an open-label single-arm clinical trial that will be conducted at Peking Union Medical College Hospital in Beijing, China. Thirty patients in suspicion of brain gliomas scheduled for surgical treatment will be recruited and subjected to PET/CT via intravenous injection of 68Ga-NOTA-Aca-BBN(7-14). The primary outcome measure will be the standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in brain glioma at 30 minutes after injection. Secondary outcomes include the diagnostic accuracy rate of 68Ga-NOTA-Aca-BBN(7-14) PET/CT, and adverse events after injection. Discussion: Diagnostic performance and safety assessment of 68Ga-NOTA-Aca-BBN(7-14) in brain gliomas will provide new insights into the specific PET/CT diagnosis of brain gliomas. Trial registration: ClinicalTrials.gov identifier: NCT02520882, registered on 2 August 2015. Ethics: This study protocol has been approved by the Ethics Committee of Peking Union Medical College Hospital in China (approval No. S-714), and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: An informed consent will be obtained from each patient or his/her guardian prior to participation in the study.