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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06108206
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Columbia University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tony J. Wang, MD
Principal Investigator Affiliation Columbia University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Anaplastic Astrocytoma, Astrocytoma, Anaplastic Oligodendroglioma
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Recruiting

Address

Columbia University Irving Medical Center

New York, New York, 10032

Site Contact

Mariamne Reyna

[email protected]

646-317-4244