Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography

F-18 florbetapir has been studied in multiple clinical trials to image beta-amyloid
deposition in the brain of subjects with Alzheimers' disease. Florbetapir F-18 has been well
tolerated in studies of more than 2000 human subjects. Biodistribution studies in humans
revealed predominantly hepatobiliary excretion. The tracer clears rapidly from the blood pool
in about 20 minutes. This radiotracer has been recently approved for clinical imaging of
brain amyloid in subjects with suspected Alzheimers disease. The investigators propose to
test this FDA approved radiotracer for an off label indication in a pilot study to evaluate
its potential utility, if any, to image cardiac amyloidosis.

Amyloid related heart disease is associated with LV wall thickening due to infiltration;
however, this myocardial wall thickening is not definitively distinguishable from left
ventricular myocyte hypertrophy from increased afterload to the heart from hypertension or
aortic stenosis. Typically myocardial or other tissue biopsy with typical echo features of
amyloidosis is required for confirmation of amyloidosis. This pilot study is designed to
understand whether cardiac amyloid burden can be measured using a specific radiotracer
targeted against amyloid protein (F-18 Florbetapir). At this point it is unknown of F-18
Florbetapir will bind to either AL or TTR amyloid protein or to both of them or to neither of
them. The investigators would like to study 15 patients with AL and 15 patients with TTR
amyloidosis to understand these differences if any. The investigators also seek to understand
if the signal to noise ratio of the circulating amyloid protein in the blood pool (AL amyloid
disease) allows for good differentiation of myocardial amyloid uptake. 15 individuals without
cardiac amyloidosis will also be enrolled as controls for this study.

The purpose of the proposed research study is to examine in detail, using quantitative PET,
myocardial F-18 Florbetapir uptake in cardiac amyloidosis in order to better understand
mechanisms of heart damage in this disease. A secondary aim of this study is to determine
reproducibility of F-18 florbetapir imaging of the myocardium.

Inclusion Criteria:

Inclusion criteria for amyloid subjects:

- Age > 18 years

- Biopsy proven amyloidosis outside the heart with typical echocardiographic appearance
of cardiac involvement, or a positive cardiac biopsy.

- Diagnosis of AL amyloidosis by standard criteria (evidence of plasma cell dyscrasia
with appropriate tissue staining for AL) OR

- Diagnosis of TTR amyloidosis (no evidence of plasma call dyscrasia and positive TTR
staining of amyloid in tissue biopsy)

- Able and willing to provide informed consent to participate in the study procedures

Exclusion Criteria:

- Pregnancy

- Serious non-cardiac medical illness which will preclude research study participation