68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Criteria

Inclusion Criteria:

• Must be able to provide a written informed consent

• Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma.

• The tumor will be surgically removed and histological diagnosis will be available.

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential；

• Known severe allergy or hypersensitivity to IV radiographic contrast；

• Inability to lie still for the entire imaging time because of cough, pain, etc.

• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.