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insufficient accrual
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| Name | Class |
|---|---|
| University of Western Ontario, Canada | OTHER |
| London Regional Cancer Program, Canada | OTHER |
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This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood flow cerebral blood volume and permeability-surface area can be generated from the DECT studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.
The clinical determination of the point of tumour progression or response is difficult to determine using standard diagnostic imaging ie CT/MRI especially following previous treatment with surgery, radiation and chemotherapy. Hemorrhage, edema, inflammation and vascular necrosis.
Both MR spectroscopy and DECT have been reported as being able to define areas of recurrent tumour as opposed to treatment-related effects. We wish to investigate the correlation between MR spectroscopy and DECT in assessing tumour progression or response to Avastin in comparison with patients not receiving Avastin.
Health Canada has approved Avastin for clinical use in patients with recurrent glioblastoma who have previously received temozolomide and radiotherapy. We propose to perform a DECT scan at baseline at presumed tumour progression and again 3 months to determine the effects of tumour progression/response on blood brain barrier permeability and vascular volume. The group of 15 patients will be compared to a group of 15 patients who do not receive Avastin at recurrence involving DECT scanning and MR spectroscopy at the time of the radiological progression and 3 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DECT/MR Spectroscopy +Avastin | Active Comparator | -15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later |
|
| DECT/MR Spectroscopy no Avastin | Active Comparator | 15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DECT | Device | DECT at tumor progression and 3 months later |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 Month Response | participants who had reduction of tumor size from avastin at 3 months | at 3 months after initial DECT and MR spectroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Fisher, MD | London Regional Cancer Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Centre | London | Ontario | N6A4L6 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | DECT/MRS in Patients Receiving Avastin | 3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks |
| FG001 | DECT/MRS in Glioma Patients Not Receiving Avastin | 0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
patients with recurrent glioblastoma
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| ID | Title | Description |
|---|---|---|
| BG000 | DECT/MRS in Patients Receiving Avastin | -15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later |
| BG001 | DECT/MRS in Glioma Patients Not Receiving Avastin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 3 Month Response | participants who had reduction of tumor size from avastin at 3 months | Posted | Number | participants who had tumor reduction | at 3 months after initial DECT and MR spectroscopy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DECT/MRS in Patients Receiving Avastin | -15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Fisher | London Health Sciences Hospital | 519-685-8650 | barbara.fisher@lhsc.on.ca |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D059906 | Neuroimaging |
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| MR spectroscopy | Device | MR spectroscopy at tumor progression and 3 months later |
|
|
15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Number | participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | DECT/MRS in Glioma Patients Not Receiving Avastin | 15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |