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

NCT06108206 | Active Not Recruiting

• 1 other identifier: AAAU2309
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Anaplastic Astrocytoma; Astrocytoma; Anaplastic Oligodendroglioma

Keywords

Adaptive Radiotherapy; High-grade glioma; Perfusion-weighted imaging; Diffusion weighted imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Estimate the progression-free and overall survival in patient with high-grade glioma.

  3 years

Study Arms (1)

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.

Interventions

Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Columbia University Irving Medical Center/NYPH

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tony J. Wang, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology (in Neurological Surgery)

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-06

Locations

US (1)