NCT01535898

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

February 13, 2012

Last Update Submit

May 4, 2017

Conditions

Keywords

MRIMR imaging Pulse SequenceHigh Resolution Diffusion-weightedQuestionnaire12-033

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

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.

Pts having an MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The radiologists on the study will identify potential research participants from those patients who are scheduled for MRI examination as part of their routine clinical care.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsProstatic Neoplasms

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Amita Dave, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 20, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations