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Trial Title:
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
NCT ID:
NCT00870129
Condition:
Brain Cancer
Glioma
Conditions: Official terms:
Glioma
Brain Neoplasms
Conditions: Keywords:
brain tumor
radiation
MRI
09-009
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
MRI and advanced MRI sequences
Description:
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.
Arm group label:
MRI
Summary:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Young, MD
Phone:
212-639-8196
Contact backup:
Last name:
Sunitha Thakur, PhD
Investigator:
Last name:
Robert Young, MD
Email:
Principal Investigator
Start date:
March 2009
Completion date:
September 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00870129
http://www.mskcc.org