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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 : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE March 26, 2009
First Posted Date  ICMJE March 27, 2009
Last Update Posted Date September 20, 2018
Actual Study Start Date  ICMJE March 2009
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
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. ]
Change History Complete list of historical versions of study NCT00870129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
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. ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Brain Cancer
  • Glioma
Intervention  ICMJE 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.
Study Arms 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018)
125
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2009)
16
Estimated Study Completion Date March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Robert Young, MD 212-639-8196
Contact: Kathryn Beal, MD
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00870129
Other Study ID Numbers  ICMJE 09-009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Young, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2018

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