Imaging Study of Glioblastomas Treated With Avastin

Malignant Gliomas Clinical Trial

Official title:

Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01549392
• Other study ID #: LRCP02
• Status: Terminated
• Phase: N/A
• First received: February 17, 2012
• Last updated: September 11, 2014
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glioblastoma
• Malignant Gliomas

Intervention

Device:
• DECT
DECT at tumor progression and 3 months later
• MR spectroscopy
MR spectroscopy at tumor progression and 3 months later

Locations

Country	Name	City	State
Canada	London Regional Cancer Centre	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
London Health Sciences Centre	London Regional Cancer Program, Canada, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 Month Response	participants who had reduction of tumor size from avastin at 3 months	at 3 months after initial DECT and MR spectroscopy	No