Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods

February 7, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

421

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of new MRI applications
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimated)

March 19, 2014

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 13-239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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