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Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

This study is currently recruiting participants.
Verified February 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581906
First received: December 21, 2007
Last updated: February 21, 2013
Last verified: February 2013
History of Changes

December 21, 2007
February 21, 2013
February 2006
February 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Identify a priori prognostic markers for head and neck cancer patients using DCE-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: February 2011 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00581906 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
To determine if the a-priori DCE-MRI and 1H-MRS results provide independent markers of tumor response and/or long term disease-free survival compared to clinical prognosticators. [ Time Frame: February 2011 ] [ Designated as safety issue: No ]
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Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Head and Neck Cancer
Radiation: DCE-MRI, DW-MRI and MRS
Patients will undergo DCE-MRI, DW-MRI and 1H-MRS study on either the 1.5T scanner or the 3T scanner prior to surgery or prior to beginning chemo-radiation therapy. Patients being treated with chemo-radiation therapy will undergo a second DCE-MRI and 1H-MRS study between 10-14 days after initiation of treatment. Those patients undergoing chemo-radiation therapy will have a second study 10-14 days after starting chemo-radiation.
pts undergoing surgery or chemo-radiation treatment
Intervention: Radiation: DCE-MRI, DW-MRI and MRS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
February 2014
February 2014   (final data collection date for primary outcome measure)

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
  • Presence of evaluable primary tumor
  • Patients must be 18 years or older and have the ability to give informed consent

Exclusion Criteria:

  • Claustrophobia
  • Absence of evaluable primary tumor
  • Known reaction to Gd-DTPA
  • Pre-operative radiation to primary tumor site

  • Contraindication to MRI

    1. Pacemaker
    2. Aneurysmal clips
    3. Metal implants in field of view
    4. Pregnant or nursing women
    5. Age and mental status wherein he/she is unable to cooperate for MRI study
Both
18 Years and older
No
Contact: Amita Dave, PhD 212-639-3184
Contact: Hilda Stambuk,, MD 212-639-2728
United States
 
NCT00581906
06-007, NIH R01 CA115895
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)
Principal Investigator: Amita Dave, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP