Malignant Gliomas
Conditions
Keywords
dynamic enhanced ct scan, mri spectroscopy, recurrent gliomas
Brief summary
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.
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.
Interventions
DEVICEDECT
DECT at tumor progression and 3 months later
DEVICEMR spectroscopy
MR spectroscopy at tumor progression and 3 months later
Sponsors
University of Western Ontario, Canada
London Regional Cancer Program, Canada
London Health Sciences Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 Month Response | at 3 months after initial DECT and MR spectroscopy | participants who had reduction of tumor size from avastin at 3 months |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| 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 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | DECT/MRS in Patients Receiving Avastin | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 3 participants | 3 participants |
| Age, Continuous | 50 years | 50 years |
| Gender Female | 2 participants | 2 participants |
| Gender Male | 1 participants | 1 participants |
| Region of Enrollment Canada | 3 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
3 Month Response
participants who had reduction of tumor size from avastin at 3 months
Time frame: at 3 months after initial DECT and MR spectroscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DECT/MRS in Patients Receiving Avastin | 3 Month Response | 3 participants who had tumor reduction |