Clinical trial NCT00581906: Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors
Official title: Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Head Cancer
Neck Cancer
Dynamic Contrast Enhanced MRI
Magnetic Resonance Spectroscopy (MRS)
Diffusion Weighted MRI (DW-MRI)
06-007
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-12-28
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

Brief summary: 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.


Eligibility 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
* 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

  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

Primary outcomes:
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.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Amita Dave, PhD
role: PRINCIPAL_INVESTIGATOR
References: