Status:
TERMINATED
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Lead Sponsor:
Saint John's Cancer Institute
Conditions:
Acromegaly
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 med...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01861717
Start Date
May 1 2013
End Date
January 1 2016
Last Update
September 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System
Santa Monica, California, United States, 90404