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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00005083
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jeffry Alger, PhD
Principal Investigator Affiliation Jonsson Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Withdrawn
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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