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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

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ClinicalTrials.gov Identifier: NCT00870129
Recruitment Status : Recruiting
First Posted : March 27, 2009
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to assess the ability of these advanced MRI scans in predicting areas within a malignant glioma (brain tumor) that are at a high risk of recurring. If these advanced MRI scans are able to identify the cancerous part of the tumor, then radiation therapy can be targeted to those sites and possibly improve patient survival.

Condition or disease Intervention/treatment Phase
Brain Cancer Glioma Procedure: MRI and advanced MRI sequences Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : March 2009
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. feasibility of 2HG spectroscopy [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870129


Contacts
Contact: Robert Young, MD 212-639-8196
Contact: Kathryn Beal, MD

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Robert Young, MD         
Contact: Kathryn Beal, MD         
Principal Investigator: Robert Young, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Robert Young, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00870129     History of Changes
Other Study ID Numbers: 09-009
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
brain tumor
radiation
MRI
09-009

Additional relevant MeSH terms:
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases