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NCT00005083 Clinical Trial

Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors

Brain and Central Nervous System Tumors Clinical Trial

Official title:
Defining Functional Tissue in Brain Tumors With Integrated Neuroimaging (Pilot Study)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00005083
Other study ID # CDR0000067692
Secondary ID UCLA-9712069NCI-
Status Withdrawn
Phase Phase 2
First received April 6, 2000
Last updated October 2, 2012
Start date March 1998

Study information
Verified date October 2012
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: New imaging procedures, such as functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging, may improve the ability to detect the extent of cancer in the brain.

PURPOSE: Phase II trial to study the effectiveness of functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly diagnosed brain tumors.

Description:

OBJECTIVES: I. Determine the definable topospecific relationship between functional neuroactivation measured by functional magnetic resonance imaging (fMRI) and chemostructural tissue measurements made with 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI) in patients with newly diagnosed brain tumors situated in the vicinity of the brain's language and motor regions. II. Determine if clinical improvement correlates with stronger imaging signatures of neuroactivation on fMRI in this patient population. III. Determine if functional loss during tumor recurrence or progression correlates with increases in choline and decreases in N-acetylaspartate on 1H-NMRSI in regions that previously displayed activation on fMRI or in associated underlying white matter regions in these patients.

OUTLINE: Patients undergo preoperative functional magnetic resonance imaging (fMRI), 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), and conventional contrast MRI over 2 hours followed by neurofunctional motor and/or language neurofunctional testing. Intraoperatively, patients undergo corticography consisting of awake language mapping and motor cortex stimulation. Patients undergo repeat imaging and neurofunctional evaluation at 2 weeks following surgery and prior to any radiotherapy or chemotherapy. Patients also undergo neurological and neuropsychological testing consisting of basic gait, motor coordination, reflexes, hand motor, tongue motor, and language evaluation to measure baseline, preoperative, and postoperative clinical status and outcomes. Patients are followed every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 4 years.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility DISEASE CHARACTERISTICS: Newly diagnosed brain tumor Neuroradiological and clinical evidence of probable glioma Lesion in close proximity to language and motor areas No prior resection

PATIENT CHARACTERISTICS: Age: 18 to 55 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other medical or psychiatric disorder No contraindications to MRI scanning (e.g., metal implants, dental prostheses other than fillings, contrast allergies)

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• conventional surgery

• magnetic resonance imaging

• magnetic resonance spectroscopic imaging

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)
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