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Completed

NCT Number: NCT00984074

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood-oxygen-level-dependent functional magnetic resonance imaging

Procedure

diffusion tensor imaging

Procedure

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Procedure

functional magnetic resonance imaging

Procedure

Intensity-Modulated Radiation Therapy

Radiation

radiation therapy treatment planning/simulation

Radiation

Primary outcomes

  1. 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

  1. Summary parameters of the dose volume histograms to the functional regions identified

    Time frame: One year

  2. Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 24, 2009
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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