• Users Online: 68
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 
STUDY PROTOCOL
Year : 2017  |  Volume : 2  |  Issue : 1  |  Page : 23-29

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


PET Center, Department of Nuclear Medicine and Beijing Key Laboratory of Nuclear Medicine in Molecular Targeted Diagnosis and Therapy, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China

Correspondence Address:
Zhao-hui Zhu
PET Center, Department of Nuclear Medicine and Beijing Key Laboratory of Nuclear Medicine in Molecular Targeted Diagnosis and Therapy, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing
China
Login to access the Email id

Source of Support: This study was supported by the Peking Union Medical College Scholar Project, China., Conflict of Interest: None


DOI: 10.4103/2542-3932.198959

Rights and Permissions

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.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1225    
    Printed52    
    Emailed0    
    PDF Downloaded110    
    Comments [Add]    

Recommend this journal