Glioblastoma Clinical Trial
Official title:
Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma
The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histopathologically proven diagnosis of glioblastoma, anaplastic astrocytoma, or anaplastic oligodendroglioma - History and physical examination within 28 days prior to enrollment - Karnofsky performance status 70 or greater - Age 18 years or greater - Negative pregnancy test for females of childbearing potential before 1st research MRI, performed in accordance to institutional guidelines. - Plan to receive 59.4-60 Gy in 30-33 fractions of radiotherapy. Glioblastoma patients over 65 year-old can receive hypofractionated radiotherapy including 40 Gy in 15 fractions. Exclusion Criteria: - Prior therapy for tumor except for biopsy or resection, including prior radiotherapy to the brain. - Clinical or radiological evidence of metastatic disease outside the brain - Prior malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Varian Medical Systems |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prediction of progression of disease in patients with high-grade glioma. | To compare the volume of the current standard of care conedown volume definition with an MRI-based adaptive plan in predicting the location of disease progression in patients with high-grade glioma. | 3 years | |
Secondary | Estimate the progression-free and overall survival in patient with high-grade glioma. | Assess the prognostic and predictive value of highly-diffusion weighted and perfusion-weighted imaging in estimating progression-free and overall survival in patients with high-grade glioma. | 3 years |
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