A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth
 hormone) the treatment is to have it surgically removed. This study has two phases.

 The first phase provides medical treatment with a drug that will be provided for 3 months
 before surgery to see if complications of surgery are reduced and to see whether or not
 remission improves following surgery if you have this medical treatment. The drug
 administered is approved by the FDA for long-term treatment of acromegaly. It is not
 routinely administered before surgery, and is therefore experimental as used in this way. All
 other procedures performed during this research are standard of care with the exception of
 the 3 questionnaires to be completed at each visit.

 The second phase of this study is from 3 months until 12 months after surgery and is only for
 people who do not go into remission after the operation. This phase assesses the possible
 remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months.
 The drug will be prescribed by your physician as part of your regular medical care and will
 not be included as part of the study. All other procedures performed during this research are
 standard of care with the exception of the 3 questionnaires to be completed at each visit.

 The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.
Inclusion Criteria:

 -  age 18 - 75

 -  elevated serum IGF-1 level above age- and sex-based normal values and failure of
 growth hormone(GH) suppression to < 1.0 ng/ml after a 75 gm oral glucose tolerance
 test (OGTT) American Association of Clinical Endocrinolgists (AACE) Acromegaly
 Clinical Guidelines 2004

 -  visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary MRI
 without and with gadolinium

 -  prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are
 acceptable if these therapies have been discontinued for at least 3 months prior to
 study entry

 Exclusion Criteria:

 -  Age < 18 or > 75 years

 -  acromegalic patients currently on a lanreotide or octreotide preparation or on
 pegvisomant

 -  patients who have received prior radiotherapy or radiosurgery

 -  patients with adenoma-related visual acuity or visual field deficit from optic nerve
 and/or chiasm compression or severe optic nerve/chiasm compression in the setting of
 normal visual fields and acuity

 -  patients with pituitary apoplexy defined as recent tumor hemorrhage and/or infarction
 on MRI with associated symptoms of new onset visual loss, diplopia and/or adrenal
 insufficiency