Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers

This study has been completed.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center. Identifier:
First received: February 13, 2012
Last updated: February 5, 2015
Last verified: February 2015

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. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.

Condition Intervention
Head and Neck Cancer
Prostate Cancer
Other: MRI scanner with sequence

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers

Resource links provided by NLM:

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

Primary Outcome Measures:
  • feasibility of high resolution diffusion-weighted imaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    using a new DWI pulse sequence from the manufacturer (General Electric Medical Systems (Milwaukee, WI)) for the assessment of head and neck cancer cancer and prostate cancer.

Enrollment: 10
Study Start Date: February 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pts having an MRI
This is a technology assessment protocol. The study is designed to assess the utility of the technology using a limited number of participants.
Other: MRI scanner with sequence
The intervention for the patients is the additional 10 minutes in the MRI scanner with sequence. The intervention for the volunteers is the scan, which will take a total of 30 minutes. The volunteers will have two more additional studies at 1-2 week intervals. Both the patients and volunteers will also need to fill out a questionnaire.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults aged 18 and over.
  • Men and women without regard to ethnic background.
  • Patients/Subjects able to give informed consent
  • Patients/Subjects whose weight does not exceed 275 lbs.
  • Patient with a known or suspected head and neck cancer or prostate cancer scheduled for an MRI scan as part of their routine care --OR--
  • Volunteer with no history of the disease in that category.

Exclusion Criteria:

  • Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
  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 identifier: NCT01535898

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Principal Investigator: Amita Dave, PhD Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center. Identifier: NCT01535898     History of Changes
Other Study ID Numbers: 12-033
Study First Received: February 13, 2012
Last Updated: February 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
MR imaging Pulse Sequence
High Resolution Diffusion-weighted

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on March 03, 2015