Status:
COMPLETED
Diffusion Tensor MRI to Distinguish Brain Tumor Recurrence From Radiation Necrosis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Glioma Tumor Recurrence
Radiation Necrosis
Eligibility:
All Genders
21+ years
Brief Summary
This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI) for distinguishing injured brain tissue due to radiation therapy (radia...
Detailed Description
The most common major side effect of radiation therapy for the treatment of primary brain tumors is the necrosis of normal brain tissues (radiation necrosis). Radiation necrosis typically occurs weeks...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must:
- Have a histologically confirmed glioma, for which radiation therapy has been previously administered.
- Be able to undergo an MRI scan of the brain.
- Have contrast enhancing lesions that are amendable to surgical biopsy and/or resection.
- Be appropriate for an operative procedure as determined by a neurosurgeon and anesthesiologist.
- Ten patient controls will be included in this study to foster technical development and for the acquisition of normative data. Patient controls will have defined unilateral abnormalities on previously obtained MRI scans, but will not have had radiation treatment.
- Be greater than or equal to 21 years of age.
- EXCLUSION CRITERIA:
- Patients must not:
- Have any of the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or auto defibrillator, cochlear implant, ocular foreign body or implant (e.g. metal shavings, retinal clips), or insulin pump as these items would be contra-indications to undergoing an MRI scan.
- Be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses - the risk of undergoing general anesthesia outweighs the potential benefit of the clinical information gained from a surgical biopsy/resection.
- Have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3) - the risk of developing uncontrollable intra-operative bleeding outweighs the potential benefit of the clinical information gained from a surgical biopsy/resection.
- Significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol - self explanatory.
- Acute or untreated infections (viral, bacterial or fungal) - patients with active infections are highly likely to have spread of their infections to the brain as a result of a biopsy/resection.
- Be pregnant at the time of the treatment - Women who are pregnant or nursing are excluded from this protocol. Therefore, all women of childbearing potential will have a pregnancy test performed, which must be negative, before proceeding. General anesthesia and surgery may subject the fetus to unacceptable risks. Also, the NIH does not offer full obstetrical services in the event that medical care to the mother and/or fetus is required.
Exclusion
Key Trial Info
Start Date :
January 27 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 20 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00285324
Start Date
January 27 2006
End Date
August 20 2013
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892