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Imaging Study of Glioblastomas Treated With Avastin

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ClinicalTrials.gov Identifier: NCT01549392
Recruitment Status : Terminated (insufficient accrual)
First Posted : March 9, 2012
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborators:
University of Western Ontario, Canada
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
Barbara Fisher, London Health Sciences Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Gliomas Device: DECT Device: MR spectroscopy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: DECT/MR Spectroscopy +Avastin
-15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) 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:
  • MRI scanner: Siemens 3T Tim Trio
  • Sequences: T1W, DTI
  • Analysis software: Brain voyager
Active Comparator: DECT/MR Spectroscopy no 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:
  • MRI scanner: Siemens 3T Tim Trio
  • Sequences: T1W, DTI
  • Analysis software: Brain voyager


Outcome Measures
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Primary Outcome Measures :
  1. 3 Month Response [ Time Frame: at 3 months after initial DECT and MR spectroscopy ]
    participants who had reduction of tumor size from avastin at 3 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549392


Locations
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Canada, Ontario
London Regional Cancer Centre
London, Ontario, Canada, N6A4L6
Sponsors and Collaborators
London Health Sciences Centre
University of Western Ontario, Canada
London Regional Cancer Program, Canada
Investigators
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Principal Investigator: Barbara J Fisher, MD London Regional Cancer Program
More Information
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Responsible Party: Barbara Fisher, Dr, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01549392    
Other Study ID Numbers: LRCP02
First Posted: March 9, 2012    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Barbara Fisher, London Health Sciences Centre:
dynamic enhanced ct scan
mri spectroscopy
recurrent gliomas
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue