Non-invasive Quantification of Liver Iron With MRI

NCT02425956 | Completed Results

• 1 other identifier: 114-2014-GES-0039
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to build a library of prospectively collected clinical data from subjects with iron overload examined with commercially available MRI devices. This data library is intended for use in future engineering development and other research activities, including future regulatory submissions.

Conditions

Iron Overload

Outcome Measures

Primary Outcomes (1)

• Per Subject Evaluable DICOM Data Sets From Liver MRI

  The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2\* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.

  48 hours pre or 24 hours post blood draw

Secondary Outcomes (1)

• Serum Ferritin Based on Blood Draw

  48 hours post MR scan or 24 hours pre MR scan

Study Arms (1)

MRI imaging of liver

EXPERIMENTAL

GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®

Device: GE Optima/Discovery® MRI data of the liver

Interventions

GE Optima/Discovery® MRI data of the liver DEVICE

GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer

Also known as: GE Optima/Discovery® MRI, FerriScan® (Resondence Health), GE IDEAL IQ®

MRI imaging of liver

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least ten (10) years of age;
• Have clinical history of iron overload;
• If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by the medical co-investigator and/or a delegated physician on the study staff or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before participating in study procedures;
• Provide evidence of willingness to participate by providing written informed consent to participate OR, if aged less than 18 years (\<18) be willing to provide written assent to participate and have parent(s) or legal guardian(s) willing to provide written informed consent for the subject's participation;
• Be able to hear and understand instructions without assistive devices;
• Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
• Be able to remain relatively motionless for the expected duration of imaging procedures (maximum of approximately 90 minutes).

You may not qualify if:

• Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities;
• Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
• Are scheduled for surgery, changes in dosage or type of chelating medications, or other medical interventions in between blood draw and MRI scanning that could be expected to impact study results or conduct;
• Have had or plan to have a change in dosage or type of chelating medications (such as Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure (blood draw or MRI, whichever comes first);
• Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment;
• Have previously participated in this study.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Research Manager
• Organization: GE Healthcare

Sandhya.Parameswaran@med.ge.com

262-521-6819

Study Officials

• Frank Korosec, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)