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

Not Applicable

Recruiting

• Conditions: Glioblastoma; Anaplastic Oligodendroglioma; Anaplastic Astrocytoma; Astrocytoma
• Interventions: Other: Adaptive Radiotherapy

• Registration Number: NCT06108206
• Lead Sponsor: Columbia University

Brief 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.

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 Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-10-30
• Study Start: 2024-01-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adaptive Radiotherapy	Adaptive Radiotherapy	Subjects will receive radiotherapy per standard of care over 30-33 once-daily fractions in addition to 7 brain MRIs each in every week of treatment. Subjects receiving hypofractionated radiotherapy will receive radiotherapy per standard of care over 15 once-daily fractions in addition to 4 brain MRIs each in every week of treatment.

Primary Outcome Measures

Name	Time	Method
Prediction of progression of disease in patients with high-grade glioma.	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Estimate the progression-free and overall survival in patient with high-grade glioma.	3 years	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center/NYPH; 🇺🇸 New York, New York, United States