Imaging Study of Glioblastomas Treated With Avastin

NCT ID: NCT01549392

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-03-31

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.

Conditions

Malignant Gliomas

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

DECT

Intervention Type: DEVICE

DECT at tumor progression and 3 months later

MR spectroscopy

Intervention Type: DEVICE

MR spectroscopy at tumor progression and 3 months later

DECT/MR Spectroscopy no Avastin

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

Group Type: ACTIVE_COMPARATOR

DECT

Intervention Type: DEVICE

DECT at tumor progression and 3 months later

MR spectroscopy

Intervention Type: DEVICE

MR spectroscopy at tumor progression and 3 months later

Interventions

DECT

DECT at tumor progression and 3 months later

Intervention Type: DEVICE

MR spectroscopy

MR spectroscopy at tumor progression and 3 months later

Intervention Type: DEVICE

Other Intervention Names

3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare; MRI scanner: Siemens 3T Tim Trio; Sequences: T1W, DTI; Analysis software: Brain voyager

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

London Regional Cancer Program, Canada

OTHER

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Barbara Fisher

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara J Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program

Locations

London Regional Cancer Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

LRCP02

Identifier Type: -

Identifier Source: org_study_id