- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336618
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population (DFWRegistry)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway.
Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake.
A total of 100 participants will be enrolled over a period of 1 year.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Carlos Duncker, MD, PhD
- Phone Number: 210-251-0040
- Email: carlos.duncker@perspectum.com
Study Contact Backup
- Name: Carlos Pantoja, Md, PhD
- Phone Number: 415-812-2560
- Email: carlos.pantoja@perspectum.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75201
- Perspectum Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female volunteers aged 18 years and over•
- Participant willing and able to give informed consent for participation in the registry.
Exclusion Criteria:
- The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC-236
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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