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Imaging Study of Glioblastomas Treated With Avastin

Primary Purpose

Malignant Gliomas

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
DECT
MR spectroscopy
Sponsored by
London Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Gliomas focused on measuring dynamic enhanced ct scan, mri spectroscopy, recurrent gliomas

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Regional Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DECT/MR Spectroscopy +Avastin

DECT/MR Spectroscopy no Avastin

Arm Description

-15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later

15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1

Outcomes

Primary Outcome Measures

3 Month Response
participants who had reduction of tumor size from avastin at 3 months

Secondary Outcome Measures

Full Information

First Posted
February 17, 2012
Last Updated
September 11, 2014
Sponsor
London Health Sciences Centre
Collaborators
University of Western Ontario, Canada, London Regional Cancer Program, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01549392
Brief Title
Imaging Study of Glioblastomas Treated With Avastin
Official Title
Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
insufficient accrual
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London Health Sciences Centre
Collaborators
University of Western Ontario, Canada, London Regional Cancer Program, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Gliomas
Keywords
dynamic enhanced ct scan, mri spectroscopy, recurrent gliomas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DECT/MR Spectroscopy +Avastin
Arm Type
Active Comparator
Arm Description
-15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later
Arm Title
DECT/MR Spectroscopy no Avastin
Arm Type
Active Comparator
Arm Description
15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
Intervention Type
Device
Intervention Name(s)
DECT
Other Intervention Name(s)
3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare
Intervention Description
DECT at tumor progression and 3 months later
Intervention Type
Device
Intervention Name(s)
MR spectroscopy
Other Intervention Name(s)
MRI scanner: Siemens 3T Tim Trio, Sequences: T1W, DTI, Analysis software: Brain voyager
Intervention Description
MR spectroscopy at tumor progression and 3 months later
Primary Outcome Measure Information:
Title
3 Month Response
Description
participants who had reduction of tumor size from avastin at 3 months
Time Frame
at 3 months after initial DECT and MR spectroscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Fisher, MD
Organizational Affiliation
London Regional Cancer Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada

12. IPD Sharing Statement

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Imaging Study of Glioblastomas Treated With Avastin

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