MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00984074

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Outcome Measures

Primary Outcome Measures

Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation [90 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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