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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00984074
First received: September 23, 2009
Last updated: February 24, 2011
Last verified: September 2009

September 23, 2009
February 24, 2011
October 2008
September 2010   (final data collection date for primary outcome measure)
Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00984074 on ClinicalTrials.gov Archive Site
  • Summary parameters of the dose volume histograms to the functional regions identified [ Designated as safety issue: No ]
  • Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation [ Designated as safety issue: No ]
Same as current
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MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer
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

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.

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.

Observational
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
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September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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United States
 
NCT00984074
CDR0000654169, UPCC-808258
Not Provided
Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Harry Quon, MD Abramson Cancer Center of the University of Pennsylvania
Investigator: Michael Mehler Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP