- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581906
Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors
Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a substance used to make specific organs, blood vessels, or tumors easier to see) that is given by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains chemical information from the tumor. During MRS, signals are detected from the chemicals (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS give extra information which is not available with the regular MRI. The regular MRI only shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels of the tumor. DW-MRI provides information related to the state of the tumor tissue with regards to the quality or condition of cells present in it and MRS gives information about the chemical makeup of the tumor.
The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can predict which patients will do well with either surgery or chemo-radiation therapy. This study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the therapy is working.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with histologically proven diagnosis of head and neck cancer or patients with tumors strongly suspicious for head and neck cancer due to clinical features or FNA (fine needle aspiration) cytology assessment.
- Will undergo surgery or chemo-radiation treatment
- Patients must be 18 years or older and have the ability to give informed consent
Exclusion Criteria:
- Claustrophobia
- Known reaction to Gd-DTPA
- Pre-operative radiation to primary tumor site
Contraindication to MRI
- Pacemaker
- Aneurysmal clips
- Metal implants in field of view
- Pregnant or nursing women
- Age and mental status wherein he/she is unable to cooperate for MRI study
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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pts undergoing surgery or chemo-radiation treatment
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Pts undergo DCE-MRI, DW-MRI or 1^H-MRS studies on either the 1.5T scanner or the 3T MRI scanners.
Patients will be grouped based on their treatment: group one will include pts who undergo surgery (we will no longer accrue pts in this group) & group two will include pts who undergo chemoradiation therapy.Pts who undergo surgery will have pretreatment DCE-MRI, DW-MRI &/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner.
Pts who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI &/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite & will undergo additional recommended weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment.
Pts will undergo two recommended DCE-MRI studies (unless contraindicated) when possible.
1st intra-treatment DCE-MRI is recommended between the 1st & 2nd weeks of treatment & the 2nd intra-treatment DCE-MRI is recommended between the 3rd & 4th weeks of treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Identify a priori prognostic markers for head and neck cancer patients using DCE-MRI, DW-MRI and 1H-MRS data, which may help in stratifying patients into "good risk" and "poor risk" categories to improve outcome and quality of life.
Time Frame: 5 years
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5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine if the a-priori DCE-MRI, DW-MRI and 1H-MRS results provide independent markers of tumor response and/or long term disease-free survival compared to clinical prognosticators.
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amita Dave, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-007
- NIH R01 CA115895
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