ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Dynamic Contrast Enhanced MRI (DCE-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, June 2008

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581906
  Purpose

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. 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 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 and MRS gives information about the chemical makeup of the tumor. The purpose of this study is to see whether DCE-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 and MRS done early in treatment can tell if the therapy is working.


Condition Intervention
Head and Neck Cancer
Radiation: DCE-MRI, MRS

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Dynamic Contrast Enhanced MRI (DCE-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   200
Study Start Date:   February 2006
Estimated Study Completion Date:   February 2011
Estimated Primary Completion Date:   February 2011 (Final data collection date for primary outcome measure)

Intervention Details:
    Radiation: DCE-MRI, MRS
    Patients will undergo DCE-MRI and 1H-MRS study 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.
Detailed Description:

Our aim is to perform pretreatment dynamic contrast enhanced - magnetic resonance imaging (DCE-MRI) and proton magnetic resonance spectroscopy (1H-MRS) on 200 patients with head and neck cancer eligible for surgery or chemo-radiation treatment. The pretreatment DCE-MRI and 1H-MRS exam will add about 20 minutes of scanning time to the routine MRI study with contrast agent performed at MSKCC. Patients undergoing chemo-radiation will also have an additional followup DCE-MRI and 1H-MRS exam between 10-14 days into the course of treatment. The followup DCE-MRI and 1H-MRS exam will be about 30-35 minutes (the DCEMRI images will take about 10 minutes, the 1H-MRS images about 10 minutes and setup on the MRI table will require 10-15 minutes).

The DCE-MRI data will provide insight into the tumor pathophysiology. With proper compartmental modelling, the data will yield results on tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction, i.e. data relating to the tumor microenvironment. In addition, MR spectroscopy data show the metabolic signature of the tumor and an elevated choline level (resulting from the enhanced phospholipid cell membrane turnover associated with tumor proliferation, increased cellularity, and growth) which may serve as an indicator of active tumor and a decrease in choline may reflect tumor response. These results will determine the potential of DCE-MRI and 1H-MRS data as a priori or early markers of tumor response to chemo-radiation as well as long term disease-free survival after surgery or chemo-radiation therapy. The a priori DCE-MRI and 1H-MRS data may ultimately help physicians in selecting patient specific therapy.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigator may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study.


Criteria

Inclusion Criteria:

  1. Histologically proven diagnosis of head and neck cancer
  2. No prior treatment
  3. Will undergo surgery or chemo-radiation treatment
  4. Presence of evaluable primary tumor
  5. Patients must be 18 years or older and have the ability to give informed consent

Exclusion Criteria:

  1. Claustrophobia
  2. Absence of evaluable primary tumor
  3. Known reaction to Gd-DTPA
  4. Pre-operative radiation to primary tumor site
  5. 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581906

Contacts
Contact: Amita Dave, PhD     davea@mskcc.org    

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center     Recruiting
      New York, New York, United States, 10065
      Contact: Amita Dave, PhD         davea@mskcc.org    

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Amita Dave, PhD     Memorial Sloan-Kettering Cancer Center    
  More Information


Memorial Sloan-Kettering Cancer Center website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Amita Dave, PhD )
Study ID Numbers:   06-007, NIH R01 CA115895
First Received:   December 21, 2007
Last Updated:   June 19, 2008
ClinicalTrials.gov Identifier:   NCT00581906
Health Authority:   United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Head and Neck Cancer  
Head Cancer  
Neck Cancer  

Study placed in the following topic categories:
Head and Neck Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 06, 2008




Links to all studies - primarily for crawlers