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

Glioblastoma Clinical Trial

Official title:

Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108206
• Other study ID #: AAAU2309
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: Tony J. Wang, MD
• Phone: 212-305-5050
• Email: tjw2117[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 60 Gy in 30 fractions of radiotherapy and not hypofractionated radiotherapy and not 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.
• Current or planned treatment with any other investigational agents for high grade glioma
• 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

Related Conditions & MeSH terms

• Anaplastic Astrocytoma
• Anaplastic Oligodendroglioma
• Astrocytoma
• Glioblastoma
• Glioma
• Oligodendroglioma

Intervention

Other:
• Adaptive Radiotherapy
Each patient will undergo a brain MRI at the following time points: Baseline- within 2 weeks prior to the start of chemo-RT, Week #1- on Fractions # 4 or 5 Week #2- between Fractions # 6-10 (at least 5 days after the Week 1 MRI) Week #3- between Fractions # 11-15 (at least 5 days after the Week 2 MRI) Week #4- between Fractions # 16-20 gadolinium contrast (at least 5 days after the Week 3 MRI) Week #5- on Fractions # 24 or 25 (after the start of the Conedown) Week #6- +/- 3 days of Fraction #30 (end of RT)

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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