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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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 |
- 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 ]
- 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 2014 |
| Estimated Primary Completion Date: | February 2014 (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 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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).
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
- Pacemaker
- Aneurysmal clips
- Metal implants in field of view
- Pregnant or nursing women
- Age and mental status wherein he/she is unable to cooperate for MRI study
Contacts and Locations| Contact: Amita Dave, PhD | 212-639-3184 | |
| Contact: Hilda Stambuk,, MD | 212-639-2728 |
| 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: Hilda Stambuk, MD 212-639-2728 | |
| 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: | February 21, 2013 |
| 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 May 23, 2013