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

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

NCT ID: NCT06108206

Condition: Glioblastoma
Anaplastic Astrocytoma
Astrocytoma
Anaplastic Oligodendroglioma

Conditions: Official terms:
Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma

Conditions: Keywords:
Adaptive Radiotherapy
High-grade glioma
Perfusion-weighted imaging
Diffusion weighted imaging

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Adaptive Radiation to the Brain

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Adaptive Radiotherapy
Description: 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)
Arm group label: Adaptive Radiotherapy

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Columbia University Irving Medical Center/NYPH

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Tony Wang

Phone: 212-305-5050
Email: tjw2117@cumc.columbia.edu

Investigator:
Last name: Tony Wang, MD
Email: Principal Investigator

Start date: January 30, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Columbia University
Agency class: Other

Collaborator:
Agency: Varian Medical Systems
Agency class: Industry

Source: Columbia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06108206