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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984074
• Other study ID #: CDR0000654169
• Secondary ID: 808258
• Status: Completed
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• blood-oxygen-level-dependent functional magnetic resonance imaging

• diffusion tensor imaging

• dynamic contrast-enhanced magnetic resonance imaging

• functional magnetic resonance imaging

Radiation:
• intensity-modulated radiation therapy

• radiation therapy treatment planning/simulation

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasability, as assessed by the proportion of study patients with functional regions identified within the brain as receiving exit irradiation		90 days
Secondary	Summary parameters of the dose volume histograms to the functional regions identified		One year
Secondary	Cerebral blood flow and blood volume quantitated by relative measures normalized to regions of the brain not receiving any irradiation		90 days

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database