A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | January 2016 |
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
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.
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
We found this trial at
1
site
Santa Monica, California 90404
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