MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00984074|
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : April 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Procedure: blood-oxygen-level-dependent functional magnetic resonance imaging Procedure: diffusion tensor imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: functional magnetic resonance imaging Radiation: intensity-modulated radiation therapy Radiation: radiation therapy treatment planning/simulation|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|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|
|Actual Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
- Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation [ Time Frame: 90 days ]
- Summary parameters of the dose volume histograms to the functional regions identified [ Time Frame: One year ]
- Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984074
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Harry Quon, MD||Abramson Cancer Center of the University of Pennsylvania|