Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00285324 : Diffusion Tensor MRI to Distinguish Brain Tumor Recurrence From Radiation Necrosis
PhaseN/A
AgesMin: 21 Years Max: N/A
Eligibility
- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00285324      |      Link to official Clinicaltrials.gov listing
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