Non-invasive Quantification of Liver Iron With MRI

Completed · Not applicable

Conditions studied: Iron Overload

In brief

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.

Key facts

Study ID

NCT02425956

Run by

GE Healthcare

People needed

21

Starts

2015-04-01

Expected to finish

2016-06-30

Last updated by the study team

2017-07-24

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.