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

NCT ID: NCT06108206

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2027-12-31

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.

Conditions

Glioblastoma; Anaplastic Astrocytoma; Astrocytoma; Anaplastic Oligodendroglioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptive Radiotherapy

Intervention Type: OTHER

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)

Interventions

Adaptive 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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Tony Jau Cheng Wang

Professor of Radiation Oncology (in Neurological Surgery)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tony J. Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center/NYPH

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tony J. Wang, MD

Role: CONTACT

tjw2117@cumc.columbia.edu

212-305-5050

Radiation Oncology Research Department

Role: CONTACT

212-305-5050

Facility Contacts

Tony Wang

Role: primary

tjw2117@cumc.columbia.edu

212-305-5050

Other Identifiers

AAAU2309

Identifier Type: -

Identifier Source: org_study_id