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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glioblastoma; Astrocytoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma
• Intervention / Treatment: Other: Adaptive Radiotherapy

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/NYPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Residents of New York or commutable distance for treatment and follow up.

Description

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 standard of care 59.4-60 Gy in 30-33 fractions of radiotherapy. Glioblastoma patients over 65 year-old can receive standard of care 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with primary high-grade glioma; Patients will receive standard of care radiotherapy over 30-33 once-daily fractions. Subjects receiving hypofractionated radiotherapy will receive radiotherapy per standard of care over 15 once-daily fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Tony J. Wang, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Diffusion weighted imaging; High-grade glioma; Adaptive Radiotherapy; Perfusion-weighted imaging
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma; Astrocytoma; Oligodendroglioma
• Other Study ID Numbers: AAAU2309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No