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

Phase 1

Completed

• Conditions: Glioblastoma; Glioma

• Registration Number: NCT00250211
• Lead Sponsor: AHS Cancer Control Alberta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-11-04
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-08
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2011-10
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
determine tumor response and pattern of failure using functional MRI imaging	Study completion
time to disease progression	Study completion

Secondary Outcome Measures

Name	Time	Method
survival
distinguish residual tumor from treatment-related necrosis	study completion
acute late toxicity of tomotherapy and hypofractionation

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada