Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods

Healthy Clinical Trial

Official title:

Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02091518
• Other study ID #: 13-239
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 421
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Ceretype, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of new MRI applications	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

External Links

•   Memorial Sloan Kettering Cancer Center