Glioma
Conditions
Keywords
fluorescence guided surgery; dual-modality imaging
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 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.
Detailed description
Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. 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 glioma. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.
Interventions
PET/NIR fluorescent imaging-guided surgery
Sponsors
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Chinese Academy of Sciences
Deling Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
In the first stage, a small proportion of participants receive preoperative 68Ga-IRDye800-BBN PET/CT and then
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas | 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 lower grade glioma will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence | 1 year | The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence, and the preoperative PET and MRI imaging indicator for IRDye800CW-BBN fluorescence imaging in lower grade gliomas |
Countries
China
Outcome results
None listed