Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors
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|ClinicalTrials.gov Identifier: NCT00581906|
Recruitment Status : Recruiting
First Posted : December 28, 2007
Last Update Posted : March 2, 2018
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Radiation: DCE-MRI, DW-MRI and MRS|
|Study Type :||Observational|
|Estimated Enrollment :||335 participants|
|Official Title:||Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors|
|Study Start Date :||February 2006|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
|pts undergoing surgery or chemo-radiation treatment||
Radiation: DCE-MRI, DW-MRI and MRS
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581906
|Contact: Amita Dave, PhD||212-639-3184|
|Contact: Nancy Lee, MD||212-639-3341|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Amita Dave, PhD 212-639-3184|
|Contact: Nancy Lee, MD 212-639-3341|
|Principal Investigator: Amita Dave, PhD|
|Principal Investigator:||Amita Dave, PhD||Memorial Sloan Kettering Cancer Center|