Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population (DFWRegistry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336618
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Perspectum

Brief Summary:
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Device: Liver MultiScan

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Liver MultiScan
    The LiverMultiscan is a quick 15 minute, contrast free, non-invasive MRI scan that provides 3 liver metrics


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult volunteers willing to get an MRI scan for the assessment of their liver
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336618


Contacts
Layout table for location contacts
Contact: Carlos Duncker, MD, PhD 210-251-0040 carlos.duncker@perspectum.com
Contact: Carlos Pantoja, Md, PhD 415-812-2560 carlos.pantoja@perspectum.com

Locations
Layout table for location information
United States, Texas
Perspectum Inc. Recruiting
Dallas, Texas, United States, 75201
Contact: Carlos Duncker, MD, PhD       carlos.duncker@perspectum.com   
Contact: Carlos Pantoja, MD, PhD       carlos.pantoja@perspectum.com   
Sponsors and Collaborators
Perspectum
Layout table for additonal information
Responsible Party: Perspectum
ClinicalTrials.gov Identifier: NCT04336618    
Other Study ID Numbers: EC-236
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases