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Clinical Trials/NCT00984074
NCT00984074
Completed
N/A

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

Abramson Cancer Center at Penn Medicine1 site in 1 country3 target enrollmentOctober 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
3
Locations
1
Primary Endpoint
Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

OBJECTIVES: * 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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
December 2011
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation

Time Frame: 90 days

Secondary Outcomes

  • Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation(90 days)
  • Summary parameters of the dose volume histograms to the functional regions identified(One year)

Study Sites (1)

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