A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: lanreotide
Intervention description: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
Intervention MeSH terms: Lanreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: excess growth hormone; excess GH; gigantism; pituitary tumor; pituitary adenoma; growth hormone tumor; GH secreting adenoma; Somatuline; lanreotide

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 - 75

          -  elevated serum Insulin-like growth factor-1 (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