Glioblastoma
Conditions
Keywords
GBM, GRPR, IRDye800, NIRF, surgery
Brief 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.
Interventions
Sponsors
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Chinese Academy of Sciences
Beijing Tiantan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be able to provide a written informed consent * MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM
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 scanning * Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM | 1 year | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in GBM will be measured. |
| Margin assessment of positive tumors in NIRF fluorescent-guided surgery | 1 year | — |
Countries
China
Contacts
Primary ContactDeling Li, MD
Backup ContactJingjing Zhang, MD.
Outcome results
None listed