Imaging Study of Glioblastomas Treated With Avastin

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • 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:
  • MRI scanner: Siemens 3T Tim Trio
  • Sequences: T1W, DTI
  • Analysis software: Brain voyager
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:
  • MRI scanner: Siemens 3T Tim Trio
  • Sequences: T1W, DTI
  • Analysis software: Brain voyager

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549392

Contacts
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

Locations
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         
Sponsors and Collaborators
London Health Sciences Centre
University of Western Ontario, Canada
London Regional Cancer Program, Canada
Investigators
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 July 22, 2014