Imaging Study of Glioblastomas Treated With Avastin
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Malignant Gliomas |
Device: DECT Device: MR spectroscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin |
- Determination of Tumor Progression using DECT and MR spectroscopy scans [ Time Frame: after second set of DECT and MRI spectroscopy scans (average of 3 months) ] [ Designated as safety issue: No ]Dynamic Enhanced Ct imaging (DECT) is a method developed for measurement of blood-brain barrier permeability and vascular volume which can then be graphically represented by functional images. MR spectroscopy is a technique that is able to characterize biochemical, metabolic and pathologic changes of brain tissue to provide information concerning the spatial extent of cellular metabolites in the brain.
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: DECT/MRS in patients receiving Avastin
-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
|
Device: DECT
DECT at tumor progression and 3 months later
Other Name: 3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare
Device: MR spectroscopy
MR spectroscopy at tumor progression and 3 months later
Other Names:
|
|
Active Comparator: DECT/MRS in glioma patients not receiving Avastin
15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
|
Device: DECT
DECT at tumor progression and 3 months later
Other Name: 3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare
Device: MR spectroscopy
MR spectroscopy at tumor progression and 3 months later
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological diagnosis of glioblastoma with clinical or radiological evidence of progression as indicated by the RANO criteria 19
- Previous radiation and temozolomide chemotherapy
- Patients must be receiving Avastin chemotherapy as second-line treatment if in the Avastin group
- Study-specific consent
Exclusion Criteria:
- Failure to meet inclusion criteria
- Pregnant or lactating patients
- Allergy to iodine or CT contrast precludes DECT component of study
- Claustrophobia precludes MR Spectroscopy component of study
- Internal metal which would preclude an MRI scan
Contacts and Locations| Contact: Barbara J Fisher, MD | 519-685-8650 | barbara.fisher@lhsc.on.ca |
| Contact: David R Macdonald, MD | 519-685-8640 | david.macdonald@lhsc.on.ca |
| Canada, Ontario | |
| London Regional Cancer Centre | Recruiting |
| London, Ontario, Canada, N6A4L6 | |
| Contact: Barbara J Fisher, MD 519-685-8650 barbara.fisher@lhsc.on.ca | |
| Contact: David R Macdonald, MD 519-685-8640 david.macdonald@lhsc.on.ca | |
| Principal Investigator: Barbara J Fisher, MD | |
| Principal Investigator: | Barbara J Fisher, MD | London Regional Cancer Program |
More Information
No publications provided
| Responsible Party: | Barbara Fisher, Dr, London Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01549392 History of Changes |
| Other Study ID Numbers: | LRCP02 |
| Study First Received: | February 17, 2012 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by London Health Sciences Centre:
|
dynamic enhanced ct scan mri spectroscopy recurrent gliomas |
Additional relevant MeSH terms:
|
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013