Gadolinium Retention in Human Bone Tissue in Pediatric Patients

When injected into the body, gadolinium contrast medium makes certain tissues, abnormalities
or disease processes more clearly visible on a magnetic resonance imaging (MRI) scans and
therefore gadolinium based contrast agents (GBCAs) are widely used in medical imaging.
Recently, new evidence suggests that following GBCA administration, gadolinium can be
deposited in body tissues even in the presence of normal renal function. Therefore, it is
essential to ensure that significant accumulation of free Gd3+ is not occurring in the bones
of children undergoing clinical contrasted MRI scans. This is particularly important for
those pediatric patients who will undergo multiple repeated MRI exams throughout their
lifetime and thereby be exposed to a large cumulative dose of gadolinium contrast. As the
differences in stability between the various GBCAs may be a factor in gadolinium exposure,
the primary objective of this study is to assess gadolinium deposition in the bones of
pediatric patients in two patient groups: 1. patients who received IV administration of
gadolinium contrast agent (Dotarem) and 2. patients who received IV administration of
gadolinium contrast agent (MultiHance).

Once acquired the samples will be analyzed at an off-site facility, National Institute of
Standards and Technology (NIST), using standardized equipment which has been certified for
measuring gadolinium concentration in contrast agent samples. A signed agreement for the
transfer of non-proprietary biological material between MUSC and NIST covers the transfer of
the samples.

Inclusion Criteria:

- Female or male pediatric patient (patients aged newborn to 18 years old at the time of
the MRI scan).

- Patients who require cardiac surgery for clinical purposes and meet one of the
following three criteria:

1. Patients who have undergone a routine contrast-enhanced MRI using MultiHance
contrast agent only for clinical purposes.

2. Patients who have undergone a routine contrast-enhanced MRI using Dotarem
contrast agent only for clinical purposes.

3. Patients who have not been exposed to gadolinium-based contrast agent
administration

Exclusion Criteria:

- Patient with abnormal renal function (defined as eGFR MDRD<30 ml/min/1.73m2).

- Patient previously exposed to any other type of MRI gadolinium based contrast agent
either at MUSC or at an outside facility

- Pregnant or breast feeding female patient

- Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe
claustrophobia, infusion pumps, cochlear implants metallic or others according to
standard practice at MUSC).