68Ga-BNOTA-PRGD2 PET/CT in Diagnosis and Evaluation of Glioma

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

Summary

This is an open-label brain PET/CT (positron emission tomography/computed tomography) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in glioma patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤40 µg BNOTA-PRGD2) will be intravenously injected into patients in suspicion of glioma. Visual and semiquantitative method will be used to assess the PET/CT images. Brain MRI with/without enhancement and 18F-FDG PET/CT will be performed for comparison. The postoperative pathology and integrin αvβ3 and CD34 immunohistochemical stains will also be used for correlation.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Beijing Tiantan Hospital

Criteria

Inclusion Criteria:

• Males and females, ≥18 years old；

• In suspicion of brain glioma on MRI；

• 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.