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Radiation Therapy

MRI-Guided Radiation for Glioblastoma

Phase 2

Waitlist Available

Led By Hui-Kuo Shu, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist

Patients must have a Karnofsky performance status (KPS) ≥ 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year

Awards & highlights

Study Summary

This trial is testing a new way to give radiation therapy for brain tumors, using MRI to better target the tumor. The goal is to see if this new method is more effective and has fewer side effects than the current standard of care.

Who is the study for?

This trial is for patients with newly-diagnosed glioblastoma or gliosarcoma who can undergo MRI scans, have not received prior brain tumor treatments, and do not have certain medical implants that affect MRI safety. They should be in a condition to forego other cancer therapies during the trial, have specific blood counts and organ function levels within set ranges, expect to live at least 12 weeks, and be able to swallow capsules.Check my eligibility

What is being tested?

The study tests spectroscopic MRI-guided radiation therapy combined with Temozolomide chemotherapy in treating brain tumors. Spectroscopic MRI aims to better identify tumor metabolism beyond what standard MRIs show. The goal is to see if this leads to more effective radiation treatment by targeting the tumors more precisely.See study design

What are the potential side effects?

Potential side effects may include typical reactions from radiation therapy such as fatigue, skin irritation at the treatment site, headaches, nausea, hair loss near treated areas; and from Temozolomide like low blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is newly diagnosed and confirmed as glioblastoma or gliosarcoma.

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I am mostly able to care for myself but may need occasional help.

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I can swallow pills.

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I agree not to take other cancer treatments while on this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility as assessed by successful co-registration of sMRI-based treatment volumes with clinical images into the radiation treatment execution platform

Incidence of adverse event assessed by Common Terminology Criteria for Adverse Events version 4.0

Secondary outcome measures

Progression free survival (PFS)

Other outcome measures

Early evidence of GBM progression assessed by sMRI

Neurocognitive performance: Controlled Oral Word Association Test

Neurocognitive performance: Hopkins Verbal Learning Test

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: sMRI-Guided RT with TMZExperimental Treatment3 Interventions

Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1930

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,545 Total Patients Enrolled

1 Trials studying Gliosarcoma

102 Patients Enrolled for Gliosarcoma

University of MiamiOTHER

899 Previous Clinical Trials

409,698 Total Patients Enrolled

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,539 Total Patients Enrolled

2 Trials studying Gliosarcoma

32 Patients Enrolled for Gliosarcoma

Media Library

Dose-Escalated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03137888 — Phase 2

Gliosarcoma Research Study Groups: sMRI-Guided RT with TMZ

Gliosarcoma Clinical Trial 2023: Dose-Escalated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03137888 — Phase 2

Dose-Escalated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03137888 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what magnitude is participation in this trial being sought?

"At this time, this clinical trial is no longer recruiting candidates. It was originally posted on September 20th 2017 and last revised on February 16th 2022. For those in search of other available trials, there are currently 443 studies for gliosarcoma that are actively enrolling patients and 207 accepting participants for Dose-Escalated Radiation Therapy."

Answered by AI

Is Dose-Escalated Radiation Therapy officially sanctioned by the FDA?

"After thorough analysis, our team concluded that Dose-Escalated Radiation Therapy is relatively safe with a score of 2. This rating implies the presence of some evidence pointing to its safety but none for efficacy."

Answered by AI

Is this an innovative or unprecedented study?

"To date, 207 ongoing clinical trials for Dose-Escalated Radiation Therapy have been registered in 36 countries and 935 cities. The initial trial was spearheaded by Schering-Plough Corporation in 2002 and involved 60 patients over the course of Phase 2 drug approval. A total of 296 studies related to this therapy have since concluded."

Answered by AI

What findings have been discovered through prior investigations of Dose-Escalated Radiation Therapy?

"At present, there are 207 clinical trials researching Dose-Escalated Radiation Therapy. 24 of these ongoing studies have reached the third phase of testing. While the majority originate in Seoul Songpa, that brings us to a total of 4752 locations exploring this treatment option."

Answered by AI

Are participants able to sign up for this research initiative at the present moment?

"This medical study is not currently enrolling and the trial was initially published on September 20th 2017, before being last edited February 16th 2022. If you are interested in other trials, there are 443 clinical programs recruiting participants with gliosarcoma currently open as well as 207 for Dose-Escalated Radiation Therapy."

Answered by AI

What maladies does Dose-Escalated Radiation Therapy typically target?

"Dose-Escalated Radiation Therapy is generally used to treat nitrosourea treatment, though it can be employed in the management of advanced mycosis fungoides, refractory neuroblastoma, or other cases where advance directives are warranted."

Answered by AI

Recent research and studies

TomographyJournal

The Brain Imaging Collaboration Suite (brics): A Cloud Platform for Integrating Whole-brain Spectroscopic MRI into the Radiation Therapy Planning Workflow

Gurbani, Saumya, Brent Weinberg, Lee Cooper, Eric Mellon, Eduard Schreibmann, Sulaiman Sheriff, Andrew Maudsley, Mohammed Goryawala, Hui-Kuo Shu, and Hyunsuk Shim. 2019. “The Brain Imaging Collaboration Suite (brics): A Cloud Platform for Integrating Whole-brain Spectroscopic MRI into the Radiation Therapy Planning Workflow”. Tomography. MDPI AG. doi:10.18383/j.tom.2018.00028.

TomographyJournal

The Longitudinal Imaging Tracker (brics-lit):a Cloud Platform for Monitoring Treatment Response in Glioblastoma Patients

Ramesh, Karthik, Saumya S. Gurbani, Eric A. Mellon, Vicki Huang, Mohammed Goryawala, Peter B. Barker, Lawrence Kleinberg, Hui-Kuo G. Shu, Hyunsuk Shim, and Brent D. Weinberg. 2020. “The Longitudinal Imaging Tracker (brics-lit):a Cloud Platform for Monitoring Treatment Response in Glioblastoma Patients”. Tomography. MDPI AG. doi:10.18383/j.tom.2020.00001.

clinicaltrials.govStudy

Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma

Hui-Kuo Shu 2017. "Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03137888.

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