Suspended

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

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What is being tested

conventional surgery

+ magnetic resonance imaging

+ magnetic resonance spectroscopic imaging

Procedure
Who is being recruted

Neoplasms+16

+ Neoplasms by Histologic Type

+ Neoplasms by Site

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: March 1998
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: October 4, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00005083
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: October 4, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialAstrocytomaEpendymomaGlioblastomaGliomaOligodendrogliomaCentral Nervous System NeoplasmsNeuroectodermal Tumors, PrimitiveGlioma, SubependymalGliosarcoma

Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers