Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02091518
Collaborator
Weill Medical College of Cornell University (Other)
384
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126.1
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Study Details

Study Description

Brief Summary

Magnetic resonance imaging (MRI) is a diagnostic imaging method with constant progress and improvement in the way the MRI images are obtained. Many of these advances involve changes to MRI software and hardware. The goal of this study is to find out the possible benefits of new MRI techniques. This will allow us to use the new MRI methods in research and patient care.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MR Screening Questionnaire
  • Device: Magnetic Resonance Imaging Acquisition and Analysis
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: MRI

Add-On Research Patients will include patients who are scheduled for a routine clinical MRI who meet the eligibility requirements for this protocol. Protocol participation will consist of an "add-on" research. MRI scan, which will be performed any point during of the routine clinical MRI scan. Volunteers will be subjects expressing interest in participation and who meet the eligibility requirements for this protocol. No contrast enhanced research MRIs including gadolinium-based or other contrast agents will be performed in volunteers.

Behavioral: MR Screening Questionnaire
All participants will complete the MR Screening Questionnaire before the MRI exam. During the MRI exam, all participants will be observed through the window from the operator console. Verbal communication will be kept with the participant throughout the exam via a speaker system.

Device: Magnetic Resonance Imaging Acquisition and Analysis
MRI Studies: The MRI scans will be performed on a 1.5T or 3T MRI scanner. Conventional MRI studies will be performed using the standard clinical sequences. The new research sequences will be performed.at any point during the clinical exam. Total imaging time for volunteers will be 30-45 minutes.

Outcome Measures

Primary Outcome Measures

  1. feasibility of new MRI applications [5 years]

    This protocol will provide pilot data to determine the feasibility of development and optimization of new MRI acquisition and analysis method.including sequence development, optimization, and workflow and analysis/visualization tools. An investigator will view the conventional images, as well as the additional research sequences. The radiologist will then complete data forms for each image and quantitative values, as listed in the evaluation form will be recorded. After all images have been read, the radiologist will review the clinical images together with the research images, and determine whether the research sequences had any effect on their diagnostic confidence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men and women age 18 or older
Exclusion Criteria:
  • Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire for MRI

  • Patients/volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field

  • Female patients/ volunteers who are pregnant or nursing

  • Patients/ volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety

  • Patients/ volunteers from the vulnerable population, as defined by 45 CFR 46.

  • Patients at higher risk due to age, frailty, or the emergent nature of their condition

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Oguz Akin, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02091518
Other Study ID Numbers:
  • 13-239
First Posted:
Mar 19, 2014
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center

Study Results

No Results Posted as of Mar 28, 2022