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. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581906
First received: December 21, 2007
Last updated: June 16, 2014
Last verified: June 2014
  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. 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 Intervention
Head and Neck Cancer
Radiation: DCE-MRI, DW-MRI and MRS

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

Resource links provided by NLM:


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, 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 320
Study Start Date: February 2006
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pts undergoing surgery or chemo-radiation treatment Radiation: DCE-MRI, DW-MRI and MRS
Patients will undergo DCE-MRI, DW-MRI and 1H-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 patients who undergo surgery and group two will include patients who undergo chemoradiation therapy.Patients who undergo surgery will have pretreatment DCE-MRI, DW-MRI and/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner. Patients who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI and/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite and will undergo additional weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment.

  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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Amita Dave, PhD 212-639-3184
Contact: Nancy Lee, MD 212-639-3341

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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581906     History of Changes
Other Study ID Numbers: 06-007, NIH R01 CA115895
Study First Received: December 21, 2007
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Head and Neck Cancer
Head Cancer
Neck Cancer
Dynamic Contrast Enhanced MRI
Magnetic Resonance Spectroscopy (MRS)
Diffusion Weighted MRI (DW-MRI)
06-007

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014