Imaging Study of Glioblastomas Treated With Avastin

NCT01549392 | Terminated Results

• 1 other identifier: LRCP02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Gliomas

Keywords

dynamic enhanced ct scan; mri spectroscopy; recurrent gliomas

Outcome Measures

Primary Outcomes (1)

• 3 Month Response

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

  at 3 months after initial DECT and MR spectroscopy

Study Arms (2)

DECT/MR Spectroscopy +Avastin

ACTIVE COMPARATOR

-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; Device: MR spectroscopy

DECT/MR Spectroscopy no Avastin

ACTIVE COMPARATOR

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

Device: DECT; Device: MR spectroscopy

Interventions

DECT DEVICE

DECT at tumor progression and 3 months later

Also known as: 3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare

DECT/MR Spectroscopy +Avastin; DECT/MR Spectroscopy no Avastin

MR spectroscopy DEVICE

MR spectroscopy at tumor progression and 3 months later

Also known as: MRI scanner: Siemens 3T Tim Trio, Sequences: T1W, DTI, Analysis software: Brain voyager

DECT/MR Spectroscopy +Avastin; DECT/MR Spectroscopy no Avastin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre: lead
• University of Western Ontario, Canada: collaborator
• London Regional Cancer Program, Canada: collaborator

Study Sites (1)

London Regional Cancer Centre

London, Ontario, N6A4L6, Canada

Location

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy; Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological

Results Point of Contact

• Title: Barbara Fisher
• Organization: London Health Sciences Hospital

barbara.fisher@lhsc.on.ca

519-685-8650

Study Officials

• Barbara J Fisher, MD

  London Regional Cancer Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 9, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09

Locations

CA (1)