A Comparison of FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.
Phase II Study Comparing FDG-PET Versus MRI Based Target Volume Delineation in Glioblastoma and the Role of FDG-PET/CT in the Alteration of MRI Based Target Volumes.
1 other identifier
interventional
15
0 countries
N/A
Brief Summary
HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%, a sample size of 15 patients would be accrued in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMarch 10, 2010
March 1, 2010
1.3 years
March 6, 2010
March 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor infiltration defined on FDG-PET not determined to MRI
18 months
Study Arms (1)
FDG-PET
EXPERIMENTALA comparison of FDG-PET versus MRI based target volume delineation in glioblastoma and the role of FDG-PET/CT in the alteration of MRI based target volumes.
Interventions
Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma
Eligibility Criteria
You may qualify if:
- Post operative patients of documented high grade gliomas (grade III and IV)
- Patients who have not undergone any previous irradiation to brain.
- Performance Scale as defined by ECOG PS 0-3
You may not qualify if:
- Patients who are diabetic.
- Patients who are pregnant.
- Any documented contrast allergy to the agents used for imaging.
- Patients who are unable to comprehend or cooperate effectively for treatment planning.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 6, 2010
First Posted
March 10, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
March 10, 2010
Record last verified: 2010-03