IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma

• Status: Unknown status
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.

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

Details

• Lead Sponsor: Deling Li
• Collaborators: Chinese Academy of Sciences; Key laboratory of molecular imaging Chinese Academy of Sciences; National Institute for Biomedical Imaging and Bioengineering (NIBIB); Peking Union Medical College Hospital

Criteria

Inclusion Criteria:

• Must be able to provide a written informed consent

• suspected lower grade gliomas on contrast-enhanced MRI

Exclusion Criteria:

• Consisted of conditions of mental illness

• Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ)

• Any hepatic enzyme level 5 times or more than normal upper limit

• Severe allergy or hypersensitivity to IV radiographic contrast

• Claustrophobia to accept the PET/CT or PET/MRI scanning

• Pregnancy or breast feeding