Protocol Details

Two-Compartment Model of Diffusion Tensor Magnetic Resonance Imaging (DT-MRI) for the Diagnosis of Glioma tumor Recurrence versus Radiation Necrosis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	06-N-0085
Sponsoring Institute	National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 21 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Glioma; Glioblastoma Multiforme; brain Cancer; Diffusion-Weighted Magnetic Resonance Imaging; brain tumor
Recruitment Keyword(s)	brain tumor; Glioma
Condition(s)	Glioma tumor Recurrence; Radiation Necrosis; Primary brain tumor
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Neurological Disorders and Stroke

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 (radiation necrosis) from the return of a brain tumor that was previously removed (tumor recurrence). DT-MRI differs from standard MRI in the way that computers process the images; there is no difference in the experience of having the procedure done. Both radiation necrosis and tumor recurrence can occur within weeks to months following brain radiation treatment. Because the treatment and management options for the two conditions differ significantly, distinguishing the two is of critical importance. Currently, surgical biopsy is required to make this differentiation.

Healthy volunteers and patients who have received radiation therapy as part of their treatment for a brain tumor may be eligible for this study. All candidates must be at least 21 years old. Patients must have a new area of abnormality that requires a biopsy to determine whether it is a tumor recurrence or radiation necrosis. Candidates are screened with a medical history and physical examination. In addition, patients have blood and urine tests.

All participants undergo MRI and DT-MRI. MRI uses a strong magnetic field and radio waves instead of X-rays to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table that can slide in and out of the cylinder and wears earplugs to muffle loud knocking noises that occur during the scanning. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 40-60 minutes. Subjects may be asked to lie still for up to 20 minutes at a time. DT-MRI is a type of MRI that measures how water moves in the brain tissue. This technique uses the same MRI machine as conventional MRI, but the diffusion images are obtained after the normal MRI scan, and by a computer program that is installed into the machine. This completes the participation of healthy subjects.

In addition to the scans, patients undergo brain biopsy of the abnormal areas identified by MRI. Patients' commitment to the study protocol is fulfilled when the surgery is complete; they may, however, continue to receive follow-up care at the NIH Clinical Center after they complete the study. They are given the results of the biopsy so that further treatment, if necessary, can be arranged.

--Back to Top--

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.

--Back to Top--

Citations:

Ammirati M, Galicich JH, Arbit E, Liao Y. Reoperation in the treatment of recurrent intracranial malignant gliomas. Neurosurgery. 1987 Nov;21(5):607-14.

Basser PJ, Mattiello J, LeBihan D. MR diffusion tensor spectroscopy and imaging. Biophys J. 1994 Jan;66(1):259-67.

Biousse V, Newman NJ, Hunter SB, Hudgins PA. Diffusion weighted imaging in radiation necrosis. J Neurol Neurosurg Psychiatry. 2003 Mar;74(3):382-4.

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information:
John K. Park, M.D. National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health BG 35 RM 2B1002 MSC 3706 35 CONVENT DR BETHESDA MD 20892-3706 (301) 402-6935 parkjo@mail.nih.gov	Gretchen C. Scott, R.N. National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health Building 10 Room 3D20 10 Center Drive Bethesda, Maryland 20892 Not Listed SNBrecruiting@nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00285324

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

• Details on how to participate in a study
• Details on how to refer a patient to a study

NIH Clinical Studies Information Request

---

Contact the Office of Communications for:

• General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml

---

Contact the Department Clinical Research Informatics, (DCRI) for:

• Technical questions about Adobe Acrobat and the PDF format
• Technical questions about this web server

webmaster@cc.nih.gov