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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 |
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 |
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 |
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) |
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.
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). 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.
Inclusion Criteria:
Exclusion Criteria:
Contraindication to MRI
Contact: Amita Dave, PhD | davea@mskcc.org |
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10065 | |||||
Contact: Amita Dave, PhD davea@mskcc.org |
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 website 
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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 |
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