Trials / Unknown
UnknownNCT02910804
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Beijing Tiantan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-BBN-IRDye800CW | |
| DEVICE | PET/NIRF | |
| PROCEDURE | PET/NIR fluorescent imaging-guided surgery |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2016-09-22
- Last updated
- 2018-01-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02910804. Inclusion in this directory is not an endorsement.