Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response

NCT ID: NCT00994201

Last Updated: 2016-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic resonance imaging (MRI) can help predict how well the tumors will respond to combined chemotherapy and radiation treatment. The investigators hope to find a reliable method to determine whether or not a patient's cancer is responding to chemo-radiation early in their treatment using an MRI, such that that cancer treatments could be tailored to the individual more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI scans: one before the initiation of their regular treatment and the second before their second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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DCE-MRI, DW-MRI and MRS

Patients will undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), Diffusion-weighted magnetic resonance imaging (DW-MRI), Magnetic resonance spectroscopy (MRS) prior to the initiation of chemoradiation and before their second cycle of chemotherapy.

Healthy volunteers will undergo DCE-MRI, DW-MRI and MRS.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Research Foundation, Oregon

OTHER

Sponsor Role collaborator

Radiological Society of North America

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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James Tanyi

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James A. Tanyi, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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http://www.ohsu.edu

Oregon Health and Science University

Other Identifiers

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OHSU IRB00005554

Identifier Type: -

Identifier Source: org_study_id

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