MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer
NCT ID: NCT00984074
Last Updated: 2019-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3 participants
OBSERVATIONAL
2008-10-31
2011-12-31
Brief Summary
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PURPOSE: This phase I trial is studying using functional MRI to see how well it works in planning radiation therapy in patients undergoing radiation therapy to the base of the skull and/or brain for nonmetastatic head and neck cancer.
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Detailed Description
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* To determine the feasibility of applying established MRI techniques to map functional anatomic regions at potential risk in irradiated normal brain tissue of patients undergoing radiotherapy to the base of the skull and brain for head and neck neoplasms.
* To determine changes in cerebral blood flow and blood volume with perfusion MRI techniques in irradiated regions of the brain as a function of the radiation dose.
OUTLINE: Patients undergo MRI perfusion imaging and functional (fMRI) (standard structural imaging sequences, diffusion tensor imaging, arterial spin labeled perfusion imaging at rest, blood oxygen level dependent, and dynamic susceptibility contrast perfusion weighted MRI) at baseline and 3 and 6 months after completion of radiotherapy. Patients may perform tasks for fMRI studies, including finger tapping, photic stimulation with a flashing light, solving math problems, comparing shapes, giving a speech, or listening to and reciting lists of words during fMRI image acquisition. Patients also undergo daily fractionated intensity-modulated radiotherapy.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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blood-oxygen-level-dependent functional magnetic resonance imaging
diffusion tensor imaging
dynamic contrast-enhanced magnetic resonance imaging
functional magnetic resonance imaging
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed head and neck cancer that requires radiotherapy to the base of the skull
* No evidence of metastatic disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 1 year
* Not pregnant
* Negative pregnancy test
* Able to undergo standard CT simulation and radiotherapy treatment planning and delivery, including the capacity to comply with standard immobilization devices to the head and neck for daily irradiation
* Able to undergo standard MRI and deemed capable of complying with the immobilization needs and tasks required for functional MRIs
* No claustrophobia
* No patients with pacemakers, metal fragments in the eye, or certain metallic implants
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Harry Quon, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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808258
Identifier Type: -
Identifier Source: secondary_id
CDR0000654169
Identifier Type: -
Identifier Source: org_study_id
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