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Pilot Study of DCE-MRI, DW-MRI, and MRS in the Assessment of Head and Neck Cancer Response to Chemo-radiation


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

Pilot Study of DCE-MRI, DW-MRI, and MRS in the Assessment of Head and Neck Cancer Response to Chemo-radiation


DCE-MRI, DW-MRI, MRS have the potential to measure early cellular changes that occur in
response to successful therapies, such as chemoradiation, and have been demonstrated to be
early predictors not only of therapeutic response, but also of overall survival for other
malignancies. Our long-term goal is to use these imaging techniques to develop non-invasive
functional imaging methodologies that would be better predictors of pathological response
than the current clinical standard.


Inclusion Criteria:



- Histologically confirmed diagnosis of loco-regionally advanced (stage III or IV)
squamous cell carcinoma of the head and neck (oropharynx, hypopharynx and larynx)

- Age > 18 years

- No prior surgery, chemotherapy or radiation therapy for head and neck cancer

- Scheduled to receive chemoradiation for definitive therapy

Exclusion Criteria:

- Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical
device or metallic fragment, severe claustrophobia)

- Contraindications to gadolinium

- Severe, active co-morbidity

- Major medical illnesses or psychiatric impairments

- Pregnant or nursing women

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Determination of early or a prior prognostic markers of head and neck cancers, as measured by DCE-MRI, DW-MRI, and MRS, that characterize the differences between clinical responders and non-responders.

Outcome Time Frame:

September 2011

Safety Issue:

No

Principal Investigator

James A. Tanyi, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

OHSU IRB00005554

NCT ID:

NCT00994201

Start Date:

October 2011

Completion Date:

July 2014

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
Oregon Health and Science University Portland, Oregon  97201