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Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Operative GBM Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) | 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative glioblastoma multiforme patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FET-PET/MRI | Diagnostic Test | Radiation planning target volume (PTV) when planned with FET-PET/MRI to PTV when planned with conventional (Standard of Care) MRI only. 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) 180-200 megabecquerel (MBq) administered intravenously prior to PET/MRI imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI. | Volume difference measured in cubic centimetres | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in pre- and post-treatment metabolic tumor volume as determined by FET-PET. | Volume difference measured in cubic centimetres | 12 months |
| Overall and recurrence-free survival post radiation treatment. |
Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to participate in this study:
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:
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The study population will consist of both males and females over 18 years of age post maximally safe resection of glioblastoma multiforme and intent to treat with stereotactic radiation.
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| Name | Affiliation | Role |
|---|---|---|
| Amit Singnurkar | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2023 | May 16, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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|
Measured in months
| 12 months |
| Quality of life changes pre and post radiation treatment. | Units on a scale - Linear Analog Self-Assessment, score minimum = 0, score maximum = 10, higher is better | 12 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |