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Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Primary Purpose

Glioblastoma, Glioma

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Functional MRI imaging and tomotherapy

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring magnetic resonance imaging, functional, radiation therapy, temozolomide, functional imaging, concurrent chemoradiation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed glioblastoma multiforme Ages 18-65 Karnofsky Performance Scale (KPS) equal to or less than 70 Minimal neurological deficit Eligible for concurrent temozolomide chemotherapy Exclusion Criteria: Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

Sites / Locations

Cross Cancer Institute

Outcomes

Primary Outcome Measures

determine tumor response and pattern of failure using functional MRI imaging

time to disease progression

Secondary Outcome Measures

distinguish residual tumor from treatment-related necrosis

survival

acute late toxicity of tomotherapy and hypofractionation

Full Information

NCT ID

NCT00250211

First Posted

November 4, 2005

Last Updated

February 23, 2016

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00250211

Brief Title

Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Official Title

Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Glioma

Keywords

magnetic resonance imaging, functional, radiation therapy, temozolomide, functional imaging, concurrent chemoradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Functional MRI imaging and tomotherapy

Primary Outcome Measure Information:

Title

determine tumor response and pattern of failure using functional MRI imaging

Time Frame

Study completion

Title

time to disease progression

Time Frame

Study completion

Secondary Outcome Measure Information:

Title

distinguish residual tumor from treatment-related necrosis

Time Frame

study completion

Title

survival

Title

acute late toxicity of tomotherapy and hypofractionation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bassam Abdulkarim, MD

Organizational Affiliation

AHS Cancer Control Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

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