IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Drug: 68Ga-BBN-IRDye800CW
* Device: PET/NIRF
* Procedure: PET/NIR fluorescent imaging-guided surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-BBN-IRDye800CW PET/NIRF<br>The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery. | Drug: 68Ga-BBN-IRDye800CW<br> <br> * Other names: BBN-IRDye800CW;Device: PET/NIRF<br> <br> * Other names: Positron emission tomography/Near-infrared fluorescent;Procedure: PET/NIR fluorescent imaging-guided surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM | 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. | 1 year | 
| Margin assessment of positive tumors in NIRF fluorescent-guided surgery |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBM, GRPR, IRDye800, NIRF, surgery