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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.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01083719
Enrollment
15
Registered
2010-03-10
Start date
2010-04-30
Completion date
2011-08-31
Last updated
2010-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Keywords

Glioblastoma, FDG-PET, MRI

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.

Interventions

PROCEDUREFDG-PET

Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma

Sponsors

Medanta Institute of Clinical Research
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Post operative patients of documented high grade gliomas (grade III and IV) 2. Patients who have not undergone any previous irradiation to brain. 3. Performance Scale as defined by ECOG PS 0-3

Exclusion criteria

1. Patients who are diabetic. 2. Patients who are pregnant. 3. Any documented contrast allergy to the agents used for imaging. 4. Patients who are unable to comprehend or cooperate effectively for treatment planning.

Design outcomes

Primary

MeasureTime frame
Tumor infiltration defined on FDG-PET not determined to MRI18 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026