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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
Not Enrolling
Both
Pituitary Adenoma

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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 MedicineNew York, New York  10016