Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pituitary Adenoma
Both
Pituitary Adenoma
Trial Information
Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study
Inclusion Criteria:
- Carry a diagnosis of de novo acromegaly with an elevated age and sex matched IGF-I
and GH >1ng/ml at all time points during OGTT
- Have a pituitary macroadenoma
- Have clinical changes consistent with acromegaly
- Have a single random serum hGH of 12.5 ng/ml or greater
- Both the endocrinologist and surgeon must agree that the patient's health would not
be compromised by a three-month period during which time Octreotide LAR is
administered.
- Patients currently on dopamine agonist who agree to discontinue medication (2-6 week
washout required)
Exclusion Criteria:
- Pregnant or breastfeeding
- Documented loss of vision due to pituitary tumor
- Prior treatment for acromegaly other than dopamine agonists
- Inability to complete the protocol
- Intolerance to octreotide
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Does surgery improve response rate to Octreotide LAR treatment?
Outcome Description:
To determine whether surgery (debulking of pituitary tumors) improves the response rate to Octreotide LAR treatment in patients with acromegaly, when compared to Octreotide LAR therapy alone.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
David M Kleinberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NYU School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
R11104
NCT ID:
NCT01371643
Start Date:
April 2004
Completion Date:
December 2011
Related Keywords:
- Pituitary Adenoma
- Adenoma
- Pituitary Neoplasms
Name | Location |
|---|---|
| New York University School of Medicine | New York, New York 10016 |
