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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

March 26, 2009
March 27, 2009
April 5, 2018
March 2009
March 2019   (Final data collection date for primary outcome measure)
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. ]
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: 2 weeks before radiation treatment, about two months after treatment, and about every two months thereafter for the duration of the study. ]
Complete list of historical versions of study NCT00870129 on ClinicalTrials.gov Archive Site
  • 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. ]
  • feasibility of 2HG spectroscopy [ Time Frame: 2 years ]
To compare radiation therapy simulations in patients with high grade gliomas using conventional and baseline advanced MRI data. [ Time Frame: prior to and 2 months±2 weeks after radiation therapy. ]
Not Provided
Not Provided
 
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
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 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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Brain Cancer
  • Glioma
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.
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.
Intervention: Procedure: MRI and advanced MRI sequences
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
16
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Robert Young, MD 212-639-8196
Contact: Kathryn Beal, MD
United States
 
 
NCT00870129
09-009
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: Robert Young, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP