Imaging Study of Glioblastomas Treated With Avastin

This study is currently recruiting participants.
Verified March 2012 by London Health Sciences Centre
Sponsor:
Collaborators:
University of Western Ontario, Canada
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
Barbara Fisher, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01549392
First received: February 17, 2012
Last updated: March 6, 2012
Last verified: March 2012

February 17, 2012
March 6, 2012
February 2012
February 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01549392 on ClinicalTrials.gov Archive Site
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Imaging Study of Glioblastomas Treated With Avastin
Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Malignant Gliomas
  • 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:
    • MRI scanner: Siemens 3T Tim Trio
    • Sequences: T1W, DTI
    • Analysis software: Brain voyager
  • Active Comparator: DECT/MRS in patients receiving Avastin
    -15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
    Interventions:
    • Device: DECT
    • Device: MR spectroscopy
  • 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
    Interventions:
    • Device: DECT
    • Device: MR spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
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
 
NCT01549392
LRCP02
No
Barbara Fisher, London Health Sciences Centre
London Health Sciences Centre
  • University of Western Ontario, Canada
  • London Regional Cancer Program, Canada
Principal Investigator: Barbara J Fisher, MD London Regional Cancer Program
London Health Sciences Centre
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP