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A Pilot Study of Pre- and Post-operative Somatuline Depot Therapy in Acromegalic Patients Treated by Endonasal Endoscopic Surgery: Impact on Early Remission Rates and Perioperative Morbidity


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Acromegaly

Thank you

Trial Information

A Pilot Study of Pre- and Post-operative Somatuline Depot Therapy in Acromegalic Patients Treated by Endonasal Endoscopic Surgery: Impact on Early Remission Rates and Perioperative Morbidity


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Early remission of acromegaly

Outcome Description:

Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.

Outcome Time Frame:

3 months post-op

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

KELD-ESS-0413

NCT ID:

NCT01861717

Start Date:

May 2013

Completion Date:

September 2016

Related Keywords:

  • Acromegaly
  • excess growth hormone
  • excess GH
  • gigantism
  • pituitary tumor
  • pituitary adenoma
  • growth hormone tumor
  • GH secreting adenoma
  • Somatuline
  • lanreotide
  • Acromegaly

Name

Location

Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health SystemSanta Monica, California  90404