drugset / Trial / NCT03407781
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma
Phase 1
Completed
52 enrolled
Deling Li
Chinese Academy of Sciences · collabNational Institute for Biomedical Imaging and Bioengineering (NIBIB) · collabPeking Union Medical College Hospital · collab
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2016-01-01
- Primary completion
- 2018-08-17
- Completion
- 2018-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-BBN-IRDye800CW | Diagnostic / imaging agent | 40 ug | Intravenous |
| Subject | 68Ga-BBN-IRDye800CW | Diagnostic / imaging agent | 1 mg/ml | Intravenous |
| Subject | 68Ga-BBN-IRDye800CW | Diagnostic / imaging agent | 2 mg/ml | Intravenous |
| Subject | 68Ga-BBN-IRDye800CW | Diagnostic / imaging agent | 111 mbq | Intravenous |
| Subject | 68Ga-BBN-IRDye800CW | Diagnostic / imaging agent | 148 mbq | Intravenous |