Liver Fat and Iron Quantification MRI

This study will include on-going technical development work for the non-invasive diagnosis of
liver fat or iron accumulation and other abnormalities. MRI is a non-invasive imaging
technique with no known side effects. The study will utilize imaging equipment that is used
routinely in numerous hospitals and clinics around the world.

The project seeks to address optimization of the imaging methodology at 1.5 Tesla and 3.0
Tesla in the liver and abdomen in order to improve clinical evaluation and care of future
patients. Non contrast MRI studies will be performed in normal healthy subjects. In addition,
the study will include subjects with confirmed disease or who have suspicion for disease, and
are undergoing contrast or non-contrast MR imaging as part of their standard of care. Up to
fourty-two (42) male or female subjects eighteen years of age and older will be studied in
total (number includes healthy subjects and non-healthy subjects).

Currently, clinical MRI exams are of adequate spatial and temporal resolution, sufficient
quantitative accuracy, and acceptable exam duration, but improvements in each of these areas
would benefit the care of future patients. For example, improvements in spatial and temporal
resolution may confer greater conspicuity of disease and shortening the exam duration can be
expected to improve patient acceptance and minimize motion artifacts. The study explores
innovative ideas about ways to improve MRI exams to have impact in all three of these areas.

Current MRI techniques for fat and iron quantification in the liver and abdomen are
challenged by respiratory and organ motion. As a result, imaging parameters (coverage,
resolution, etc) and TE selection for fat/iron quantification are compromised to accommodate
a short breath-held 2D or 3D scan, which can still be affected by motion artifacts and even
unachievable for patients with limited breath-holding capability. Therefore, the study aims
to achieve robust free-breathing fat/iron quantification in the liver and abdomen using
innovative MRI techniques and algorithms.

Inclusion Criteria:

1. Healthy Volunteers:

- Healthy subjects 18 years or older

2. Clinical Patients:

- Patients who are 18 years or older and who are scheduled for a routine clinically
indicated MRI exam at University of California Los Angeles

Exclusion Criteria:

1. Healthy Volunteers:

- Age less than 18 years

- Subject with the following devices/implants/conditions will be excluded:

1. cardiac pacemakers

2. defibrillators

3. cochlear implants

4. intraocular metallic foreign bodies

5. intracranial aneurysm clips

6. claustrophobia

- Subjects will be excluded if they have a history of severe renal disease
(Creatinine level >2.5 mg/dl or Glomerular Filtration Rate <15 ml/minute/1.73m2 )
or allergy to MRI contrast agents ("dyes"). Healthy volunteers will not be
studied with these agents.

- Pregnant subjects will not be enrolled. Although there is no data to suggest that
MRI is harmful to the fetus, this study is limited to non-pregnant subjects.

2. Clinical Patients:

- Age less than 18 years

- Subject with the following devices/implants/conditions will be excluded:

1. cardiac pacemakers

2. defibrillators

3. cochlear implants

4. intraocular metallic foreign bodies

5. intracranial aneurysm clips

6. claustrophobia

- Subjects will be excluded if they have a history of severe renal disease
(Creatinine level >2.5 mg/dl or Glomerular Filtration Rate <15 ml/minute/1.73m2 )
or allergy to MRI contrast agents ("dyes").

- Pregnant subjects will not be enrolled. Although there is no data to suggest that
MRI is harmful to the fetus, this application is limited to non-pregnant
subjects.