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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00994201
Recruitment Status : Terminated (Study never accrued sufficient subjects)
First Posted : October 14, 2009
Last Update Posted : March 25, 2016
Sponsor:
Collaborators:
Medical Research Foundation, Oregon
Radiological Society of North America
Information provided by (Responsible Party):
James Tanyi, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date October 13, 2009
First Posted Date October 14, 2009
Last Update Posted Date March 25, 2016
Study Start Date October 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 31, 2009)
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 ]
Original Primary Outcome Measures
 (submitted: October 13, 2009)
Determination of early or a priori 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: December 31, 2009)
Correlation between early/a prior marker and progression-free survival. [ Time Frame: September 2011 ]
Original Secondary Outcome Measures
 (submitted: October 13, 2009)
Correlation between early/a priori marker and progression-free survival. [ Time Frame: September 2011 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response
Official Title Pilot Study of DCE-MRI, DW-MRI, and MRS in the Assessment of Head and Neck Cancer Response to Chemo-radiation
Brief Summary 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 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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential subjects will be recruited by the Oregon Health and Science University head and neck oncology staff.
Condition Head and Neck Cancer
Intervention Other: 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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 24, 2016)
10
Original Estimated Enrollment
 (submitted: October 13, 2009)
30
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00994201
Other Study ID Numbers OHSU IRB00005554
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James Tanyi, OHSU Knight Cancer Institute
Study Sponsor OHSU Knight Cancer Institute
Collaborators
  • Medical Research Foundation, Oregon
  • Radiological Society of North America
Investigators
Principal Investigator: James A. Tanyi, PhD Oregon Health and Science University
PRS Account OHSU Knight Cancer Institute
Verification Date March 2016