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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01535898
Other study ID # 12-033
Secondary ID
Status Completed
Phase N/A
First received February 13, 2012
Last updated May 4, 2017
Start date February 2012
Est. completion date February 2015

Study information

Verified date May 2017
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary feasibility of high resolution diffusion-weighted imaging 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. 2 years
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