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

Last updated: June 28, 2024
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glioblastoma Multiforme

Cancer/tumors

Gliomas

Treatment

Adaptive Radiotherapy

Clinical Study ID

NCT06108206
AAAU2309
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histopathologically proven diagnosis of glioblastoma, anaplastic astrocytoma, oranaplastic 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 researchMRI, performed in accordance to institutional guidelines.

  • Plan to receive 59.4-60 Gy in 30-33 fractions of radiotherapy. Glioblastoma patientsover 65 year-old can receive hypofractionated radiotherapy including 40 Gy in 15fractions.

Exclusion

Exclusion Criteria:

  • Prior therapy for tumor except for biopsy or resection, including prior radiotherapyto the brain.

  • Clinical or radiological evidence of metastatic disease outside the brain

  • Prior malignancy (except non-melanomatous skin cancer) unless disease free for aminimum of 2 years

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Adaptive Radiotherapy
Phase:
Study Start date:
January 30, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Diffusion weighted imaging (DWI) and Perfusion-weighted imaging (PWI) are validated MRI techniques that aid in diagnosis, prognosis, and assessment of treatment efficacy and, while they are utilized in select clinical settings, they have yet to make their way into routine clinical practice at most centers. DWI is a non-invasive MRI modality that has demonstrated an ability to predict for a response to radiation therapy in the primary treatment of patients with glioblastoma (GBM). PWI is one collection of measures that includes dynamic susceptibility contrast (DSC) enhancement and dynamic contrast-enhanced (DCE) imaging. The latter methods of MRI-adapted radiotherapy allow the opportunity to direct high-dose radiation to areas most likely to harbor resistant tumor while avoiding regions having a low likelihood of future recurrence. Multiple MRI sequences have been developed and validated that may identify high-risk areas in patients with High-grade glioma (HGG) and the ability to acquire multiple sequential time points creates an opportunity for dynamic radiotherapy that has not previously been explored. The current standard of care in radiotherapy does not incorporate any additional neuroimaging data.

This study hypothesizes that pre- and mid-treatment advanced imaging with (DWI) and (PWI) in patients with HGG can be used to generate an adaptive radiotherapy boost volume that correlates with areas of future recurrence and that this volume has a higher spatial correlation relative to the current standard of care.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center/NYPH

    New York, New York 10032
    United States

    Active - Recruiting

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