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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
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Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults. Despite recent diagnostic and therapeutic advances, including aggressive surgical resection and chemoradiation, the prognosis of GBM has improved only slightly over the past two decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM that contributes to poor outcome through multiple mechanisms such as 1) overexpression of enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM and 2) increase expression of cancer stem cells which are more resistant to radiation. Hypoxic tumour regions are associated with higher rates of progression and recurrence.
In this study the investigators will use an advanced MRI technique called qBOLD to non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron supplement, and utilize two recent technical advances not previously used in human tumours to quantitatively measure oxygenation in GBM.
Prior knowledge of hypoxia can assist in prognostication and individualization of treatment planning with special focus on hypoxic regions by targeted radiation dose or regimen modulation; consideration of more intensive chemotherapy regimens; more aggressive and targeted surgical resection and closer short-term clinical and imaging follow-ups.
We propose a study to demonstrate quantitative oxygen saturation estimation in GBM is feasible with qBOLD and it correlates with established histopathological markers of hypoxia and angiogenesis, and targeted intraoperative oxygen measurement.
All patients will undergo surgery as part of their standard treatment. By coregistering the hypoxia map on presurgical MRI we will be able to do the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single patient group receiving Feraheme® | Experimental | Newly diagnosed GBM patients with no prior treatment will receive Feraheme® as MRI contrast agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feraheme® | Drug | Drug will be diluted in 50 cc normal saline and infused over 15-60 minutes depending on patient condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation in GBM with qBOLD MRI and its correlation with histological markers of tissue hypoxia and angiogenesis | Pre-operative qBOLD imaging and O2 saturation mapping will be performed in 27 newly diagnosed GBM patients and targeted biopsies will be obtained from the hypoxic and non-hypoxic regions of the tumor. | Within 8 hours after the MRI exam is complete |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation in GBM with qBOLD MRI and its correlation with targeted intraoperative oxygen measurement | Volumes of interest from the hypoxic and non-hypoxic regions of the tumor will be imported into the neuronavigation system (Stryker) for targeted placement of Licox® oxygen-sensing probe (Integra NeuroSciences). | Within 8 hours after the MRI exam is complete |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pejman Jabehdar Maralani, MD FRCPC | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada | ||
| St. Michael's Hospital |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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|
| Toronto |
| Ontario |
| M5B 1W8 |
| Canada |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008903 |
| Minerals |