Head and Neck Cancer Clinical Trial
Official title:
A Pilot Study of Functional Mapping and Brain Perfusion Imaging in Patients Receiving Base of Skull and Brain Radiotherapy: Developing Neurocognitive Functional Organs At Risk for Individualized Conformal Radiotherapy
Verified date | April 2019 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging
(MRI), may help in planning radiation therapy that does less damage to normal tissues.
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation | 90 days | ||
Secondary | Summary parameters of the dose volume histograms to the functional regions identified | One year | ||
Secondary | Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation | 90 days |
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