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.

Study Overview

• Status: Terminated
• Conditions: Malignant Gliomas
• Intervention / Treatment: Device: DECT; Device: MR spectroscopy

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A4L6
      • London Regional Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 Month Response	participants who had reduction of tumor size from avastin at 3 months	at 3 months after initial DECT and MR spectroscopy

Collaborators and Investigators

• Sponsor: London Health Sciences Centre
• Collaborators: University of Western Ontario, Canada; London Regional Cancer Program, Canada
• Investigators: Principal Investigator: Barbara J Fisher, MD, London Regional Cancer Program

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 11, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: dynamic enhanced ct scan; mri spectroscopy; recurrent gliomas
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: LRCP02