- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994201
Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response
March 24, 2016 updated by: James Tanyi, OHSU Knight Cancer Institute
Pilot Study of DCE-MRI, DW-MRI, and MRS in the Assessment of Head and Neck Cancer Response to Chemo-radiation
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health and Science University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Potential subjects will be recruited by the Oregon Health and Science University head and neck oncology staff.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: September 2011
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September 2011
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between early/a prior marker and progression-free survival.
Time Frame: September 2011
|
September 2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James A. Tanyi, PhD, Oregon Health and Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
October 13, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (Estimate)
October 14, 2009
Study Record Updates
Last Update Posted (Estimate)
March 25, 2016
Last Update Submitted That Met QC Criteria
March 24, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSU IRB00005554
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on DCE-MRI, DW-MRI and MRS
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)Active, not recruitingHead and Neck CancerUnited States
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American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupUnknownBreast Cancer | BIRADS 3 | BIRADS 4 | BIRADS 5United States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
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Memorial Sloan Kettering Cancer CenterCompletedPapillary Thyroid CancerUnited States
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI); University of Iowa; Oregon Health and Science... and other collaboratorsRecruiting
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M.D. Anderson Cancer CenterCompleted
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Universitaire Ziekenhuizen KU LeuvenUnknownRecurrence | Uterine Cervical Cancer | Diffusion-weighted MRIBelgium
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University of Michigan Rogel Cancer CenterCompletedBreast CancerUnited States
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Memorial Sloan Kettering Cancer CenterWeizmann Institute of Science; Cold Spring Harbor LaboratoryCompletedPancreatic CancerUnited States
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Hunan Province Tumor HospitalSun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical...Unknown