Protocol Details

(1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	99-C-0088
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: N/A Max Age: N/A
Referral Letter Required	Yes
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Neuroimaging; Leukoencephalopathy; Cortical Atrophy; Methotrexate; Radiation
Recruitment Keyword(s)	None
Condition(s)	Cancer; Central Nervous System Disease; Nervous System Disease; Peripheral Nervous System Disease; Progressive Multifocal Leukoencephalopathy
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

Central nervous system toxicity is a recognized side effect of certain therapies for cancers, particularly cranial irradiation, intrathecal therapy or systemic high-dose chemotherapy. The pathophysiologic mechanisms and clinical manifestations vary. Previous studies defining MRI changes and correlating these with neurocognitive deficiencies have been inconsistent. Recent advances in brain imaging may help to better define neurotoxic effects. (1)H-NMRS is a noninvasive method of obtaining in vivo biochemical information from the brain. It has been used to study patients with CNS disorders, including neuronal disorders. In this study, (1)H-NMRS will be used to objectively characterize CNS toxicities in patients with cancer who are receiving potentially neurotoxic therapies. In addition, we will retrospectively evaluate patients with known or suspected neurotoxicity associated with cancer therapy, to determine if changes in spectroscopic patterns are associated with CNS toxicity.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

Patients with brain tumors or patients receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiation therapy or patients with documented or suspected clinical neurotoxicity presumed to be caused by treatment for cancer.

Durable Power of Attorney (DPA) should be offered to all patients greater than or equal to 18 years of age.

All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate, the minor patient will sign a written assent.

EXCLUSION CRITERIA:

Pregnancy.

Patients with braces or permanent retainers.

Patients with pre-existing neurologic or genetic conditions, unrelated to the tumor.

Patients who are unable (either because of physical or psychological factors) to undergo imaging studies and who are not a candidate for anesthesia.

Patients who have an absent gag reflex or swallowing difficulties.

Metallic implants, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants or ferrous surgical clips.

History of severe reaction to Gadolinium.

--Back to Top--

Citations:

Chemotherapy for acute lymphocytic leukemia: cognitive and academic sequelae

Comparison of neuropsychologic functioning and clinical indicators of neurotoxicity in long-term survivors of childhood leukemia given cranial radiation or parenteral methotrexate: a prospective study

Medulloblastoma in childhood: progressive intellectual deterioration

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information:
Katherine E. Warren, M.D. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 1W-3940 10 Center Drive Bethesda, Maryland 20892 (301) 435-4683 warrenk@exchange.nih.gov	Robyn Bent, R.N. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 1-3750 10 Center Drive Bethesda, Maryland 20892 (301) 496-4256 rbent@mail.nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937

Clinical Trials Number:

NCT00001807

--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