Clinical trial NCT06108206: Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma
Official title: Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Anaplastic Astrocytoma
Astrocytoma
Anaplastic Oligodendroglioma
Keywords: Adaptive Radiotherapy
High-grade glioma
Perfusion-weighted imaging
Diffusion weighted imaging
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adaptive Radiation to the Brain
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prediction of progression of disease in patients with high-grade glioma.
timeFrame: 3 years
Secondary outcomes:
measure: Estimate the progression-free and overall survival in patient with high-grade glioma.
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYPH
state: New York
Study officials:
affiliation: Columbia University
name: Tony J. Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: