- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091518
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Oguz Akin, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on MR Screening Questionnaire
-
University College, LondonMedical Research Council; Cancer Research UK; National Institute for Health Research... and other collaboratorsCompleted
-
Susanne WalitzaRecruitingSubstance Use DisordersSwitzerland
-
Xuanwu Hospital, BeijingNational Key Research and Development Project, ChinaCompletedStroke, Ischemic | Intracranial AtherosclerosisChina
-
Markus J. ErnstRecruitingMigraine | Tension-Type HeadacheSwitzerland
-
University of OxfordUniversity College DublinRecruiting
-
Mayo ClinicRecruiting
-
Federal State Budget Institution Research Center...Recruiting
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingScreening Breast MRI in Patients Who Are BRCA Mutation CarriersUnited States
-
Great Ormond Street Hospital for Children NHS Foundation...WithdrawnDisordered EatingUnited Kingdom
-
Lithuanian University of Health SciencesKlaipėda UniversityCompletedDysphagia | Lingual Tonsil HypertrophyLithuania