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NCT00250211 Clinical Trial

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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00250211
Other study ID # CNS-09-0027 / ethics 21780
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received November 4, 2005
Last updated February 23, 2016
Start date March 2005
Est. completion date April 2011

Study information
Verified date October 2011
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date April 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Functional MRI imaging and tomotherapy

Locations
Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (2)
Lead Sponsor Collaborator
AHS Cancer Control Alberta Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary determine tumor response and pattern of failure using functional MRI imaging Study completion
Primary time to disease progression Study completion
Secondary distinguish residual tumor from treatment-related necrosis study completion
Secondary survival
Secondary acute late toxicity of tomotherapy and hypofractionation
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