Diagnostic Study In Patients Receiving Treatment For Brain Tumors - Tabular View

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Diagnostic Study In Patients Receiving Treatment For Brain Tumors

This study is ongoing, but not recruiting participants.

Study NCT00020293. Last updated on October 18, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Diagnostic Study In Patients Receiving Treatment For Brain Tumors

Official Title ^†

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

Brief Summary

RATIONALE: New diagnostic procedures such as 1H-nuclear magnetic resonance spectroscopic imaging may be more effective than MRI in evaluating side effects of cancer therapy in patients who are receiving treatment for tumors.

PURPOSE: Diagnostic trial using 1H-nuclear magnetic resonance spectroscopic imaging and MRI of the brain in patients who are receiving cancer therapy for tumors.

Detailed Description

OBJECTIVES:

Determine the specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using 1H-nuclear magnetic resonance spectroscopic imaging in patients with cancer.

OUTLINE: Patients undergo 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), followed by gadopentetate dimeglumine IV, followed by conventional magnetic resonance imaging (MRI) prior to anticancer therapy, immediately after the first course of therapy, prior to subsequent courses of therapy, and/or after completion of all therapy. Patients may also undergo age-appropriate neuropsychological testing within 1 week of 1H-NMRSI and conventional-contrast MRI.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 2 years.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^†

Drug: gadopentetate dimeglumine
Procedure: magnetic resonance spectroscopic imaging

MEDLINE PMIDs

Links

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

March 2000

Completion Date

Eligibility Criteria ^†

DISEASE CHARACTERISTICS:

Diagnosis of brain tumor OR
Receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiotherapy OR
Documented or suspected clinical neurotoxicity presumed to be caused by anticancer treatment
No preexisting neurologic or genetic conditions unrelated to tumor

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant
Negative pregnancy test
No braces or permanent retainers
No metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants, or ferrous surgical clips
No physical or psychological factor that would preclude imaging studies
No history of severe reaction to gadolinium

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Concurrent immunotherapy allowed

Chemotherapy:

See Disease Characteristics
Concurrent chemotherapy allowed

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
Concurrent radiotherapy allowed

Surgery:

Not specified

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00020293

Organization ID

CDR0000068229

Secondary IDs ^††

NCI-99-C-0088

Study Sponsor ^†

NCI - Center for Cancer Research-Medical Oncology

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Katherine Warren, MD

NCI - Pediatric Oncology Branch

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2007

First Received Date ^†

July 11, 2001

Last Updated Date

October 18, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.