Massive Iron Deposit Assessment

NACompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

June 11, 2012

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Iron OverloadExcessive Body Iron Burden
Interventions
DEVICE

R2*-UTE

Ultra short echo time (UTE) magnetic resonance imaging (MRI). Study participants will undergo an MRI examination of the liver on a 1.5T MRI and a 3T MRI scanner each. Because liver biopsy metal needle fragments could interfere with the MRI measurements, the MRI exams will always precede liver biopsy. Multi-echo GRE sequences will be used to acquire images with increasing TEs. Images of the liver will be obtained in transversal slice orientation through the center of the liver at the level of the origin of the main portal vein. At equivalent slice locations R2\*-UTE scans will be performed.

DEVICE

R2*-GRE

Gradient-echo (GRE) magnetic resonance imaging (MRI). Study participants will undergo an MRI examination of the liver on a 1.5T MRI and a 3T MRI scanner each. Because liver biopsy metal needle fragments could interfere with the MRI measurements, the MRI exams will always precede liver biopsy. Multi-echo GRE sequences will be used to acquire images with increasing TEs. Images of the liver will be obtained in transversal slice orientation through the center of the liver at the level of the origin of the main portal vein. At equivalent slice locations R2\*-UTE scans will be performed.

PROCEDURE

Liver biopsy

Indications for liver biopsy include, but are not limited, to the need to quantify liver tissue iron and the need to obtain histopathological information of the liver tissue. Liver biopsies will only be performed if clinically indicated and will be done only once per patient. The technique to be used is coaxial percutaneous (transcapsular) technique; however, a coaxial transjugular technique may be performed in subjects with increased bleeding diathesis, since it is associated with less hemorrhagic risk. Healthy volunteers will not undergo liver biopsy.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

Regional One Health

OTHER

lead

St. Jude Children's Research Hospital

OTHER

NCT01572922 - Massive Iron Deposit Assessment | Biotech Hunter | Biotech Hunter