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| ID | Type | Description | Link |
|---|---|---|---|
| ZIAEB000073 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| Chinese Academy of Sciences | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-BBN-IRDye800CW PET/NIRF | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-BBN-IRDye800CW | Drug |
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| PET/NIRF |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deling Li, MD | Contact | ttyyneuroli@126.com | ||
| Jingjing Zhang, MD. | Contact | zhangjingjingtag@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nan Ji, MD | Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China | Study Director |
| Zhaohui Zhu, MD. | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Device |
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| PET/NIR fluorescent imaging-guided surgery | Procedure |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |