Lanreotide Levels in Acromegaly

Recently lanreotide (a somatostatin analog) has come into the US marketplace as a
commercially available medication approved by the FDA for the treatment of acromegaly. Blood
levels in patients getting this drug are unknown and it may be critical to know the levels
in patients whose symptoms are poorly controlled.

This is a clinical study of a medical device where the following condition is met: This is
research on a medical device for which an investigational device exemption application (21
CFR Part 812) is not required.

The study is exempt from IDE requirements under 21 CFR 812.2(c)(3):

The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes.
After receiving an information sheet and providing verbal consent, the participants will go
to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn,
which will be sent to Intersciences Institute in Inglewood California to have the lanreotide
plasma levels measured.

The key points of this study are:

Patients will have blood drawn at the same time as they are having blood drawn for routine
care to avoid unnecessary sticks.

No patient identifiers will be sent to the lab or to any investigators- all plasma tubes
will be coded by ISI as a kit and these kits will be given to the physicians. In turn the
physician will give the kit to the patients who wish to have their levels measured and the
patient will take the kit with them to their routine blood draw. Following the drawing and
processing of the blood we will request that the lab just drop the coded plasma tube (and
the patient's height weight and monthly lanreotide dose) into the mail in the prepaid
mailer. The only information that the investigators will receive is the patient's height,
weight and monthly lanreotide dose and the plasma lanreotide level.

No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide
measurement.

Whenever possible plasma (which would otherwise be discarded) will be used rather than
freshly drawn blood.

All plasma will be assayed at ISI.

The patient will not be charged for the lanreotide assay, an investigational assay. The
assay is currently investigational and does not have a "maker" at this time.