Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

December 27, 2023 updated by: Memorial Sloan Kettering Cancer Center

Using Advanced MR Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans: A Pilot Study, and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

The researchers think that the use of advanced MR imaging may help people with this disease, because it may better predict areas within a malignant glioma (brain tumor) that are at a high risk of recurring. WeThe reserchers are doing this study to see whether this advanced imaging is a safe treatment that causes few or mild side effects in people with brain tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sunitha Thakur, PhD
  • Phone Number: 646-608-8262

Study Contact Backup

  • Name: Robert Young, MD
  • Phone Number: 212-639-8196

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sunitha Thakur, PhD
        • Contact:
          • Robert Young, MD
          • Phone Number: 212-639-8196
        • Principal Investigator:
          • Robert Young, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation
  • May undergo radiation therapy
  • Patient and/or guardian is able to provide written informed consent prior to study registration
  • Age ≥ 18 years old

Exclusion Criteria:

  • Extreme claustrophobia that precludes MRI scan
  • Known allergic reaction to Gd-DTPA
  • Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
  • Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
  • Pregnant or nursing female
  • Unable to cooperate for MRI and/or radiation therapy planning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI
The advanced MRI studies will be obtained at the time of the routinely scheduled preoperative planning MRI and/or the routinely scheduled pre-RT planning MRI at approximately 3±2 weeks after surgery. The routine sequences obtained for the planning MRI are standard of care. The advanced MRI sequences may or may not be additional as some have already been adopted into the standard of care imaging at MSKCC.
Procedure: MRI and advanced MRI sequences
This is a nonrandomized study in which each patient will receive the standard clinical care (in the form of surgery, radiation therapy and/or chemotherapy), as per the treating physician. Surgical resection will be performed at the discretion of the treating Neurooncologist and/or Neurooncology Tumor Board. Advanced brain MRIs with the 2 (or, in some cases, 3) special sequences will be obtained at the time of the clinically scheduled contrast MRIs, which are usually obtained immediately prior to and 1 months±3 weeks after radiation therapy if the patient requires radiation therapy for his/her tumor. The advanced brain MRI may also be obtained before surgery for suspected or confirmed gliomas, as per the standard of care, in some patients who may or may not require radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the utility of baseline advanced MRI & changes between baseline & follow up advanced MRI in predicting high risk areas that are likely to develop progressive glioma despite chemoradiotherapy.
Time Frame: 1 -7 weeks before radiation treatment, about two months after treatment, and about every two months thereafter for the duration of the study.
1 -7 weeks before radiation treatment, about two months after treatment, and about every two months thereafter for the duration of the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare radiation therapy simulations in patients with gliomas using conventional and baseline advanced MRI data.
Time Frame: prior to and 1 months±3 weeks after radiation therapy.
prior to and 1 months±3 weeks after radiation therapy.
feasibility of 2HG spectroscopy
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Robert Young, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimated)

March 27, 2009

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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