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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108206
Other study ID # AAAU2309
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2024
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source Columbia University
Contact Tony J. Wang, MD
Phone 212-305-5050
Email tjw2117@cumc.columbia.edu
Is FDA regulated No
Health authority
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 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

Study Design


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) Patients receiving hypofractionated radiotherapy will undergo a brain MRI at the following time points: Baseline- within 2 weeks prior to the start of your standard of care chemotherapy radiation treatment (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)

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
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