RecruitingNot ApplicableNCT06108206

Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma

Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma


Sponsor

Columbia University

Enrollment

20 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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

Interventions

OTHERAdaptive Radiotherapy

Each patient will undergo a brain MRI at the following time points: 1. Baseline- within 2 weeks prior to the start of chemo-RT, 2. Week #1- on Fractions # 4 or 5 3. Week #2- between Fractions # 6-10 (at least 5 days after the Week 1 MRI) 4. Week #3- between Fractions # 11-15 (at least 5 days after the Week 2 MRI) 5. Week #4- between Fractions # 16-20 gadolinium contrast (at least 5 days after the Week 3 MRI) 6. Week #5- on Fractions # 24 or 25 (after the start of the Conedown) 7. Week #6- +/- 3 days of Fraction #30 (end of RT) Patients receiving hypofractionated radiotherapy will undergo a brain MRI at the following time points: 1. Baseline- within 2 weeks prior to the start of your standard of care chemotherapy radiation treatment (chemo-RT), 2. Week #1 - on Fractions #4 or 5 3. Week #2 - between Fractions #6-10 (at least 5 days after the Week 1 MRI) 4. Week #3 - between Fractions #11-15 (at least 5 days after the Week 2 MRI)


Locations(1)

Columbia University Irving Medical Center/NYPH

New York, New York, United States

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NCT06108206


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