IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
NCT02910804 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-01-18
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 glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW 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.
Conditions
Interventions
- DRUG
-
68Ga-BBN-IRDye800CW
- DEVICE
-
PET/NIRF
- PROCEDURE
-
PET/NIR fluorescent imaging-guided surgery
Sponsors & Collaborators
-
Peking Union Medical College Hospital
collaborator OTHER -
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
collaborator NIH -
Chinese Academy of Sciences
collaborator OTHER_GOV -
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Nan Ji, MD · Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China
-
Zhaohui Zhu, MD. · Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- China
Study Locations
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