Clinical Trial: Ultrasound Guided Sandostatin LAR Injection in Acromegaly

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly

Brief Summary: The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.

Detailed Summary: IM intragluteal injections have been reported to be inaccurate in their placement in the intramuscular compartment when performed as dictated by the current standard of care. This inaccuracy of placement may have an effect on the efficacy of drugs delivered by the IM route. Furthermore, the inaccuracy of IM injections was found to be directly related to BMI and was found to be more inaccurate in female subjects. Ultrasound guidance of IM injections will improve the accuracy of placement of IM injections and may improve drug levels and efficacy of Sandostatin LAR in the treatment of Acromegaly.
Sponsor: Cedars-Sinai Medical Center

Current Primary Outcome: Serum drug levels of octreotide after third month of ultrasound guided IM injection of octreotide LAR compared to third month of non-ultrasound guided IM injection of octreotide LAR [ Time Frame: 7 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections [ Time Frame: 7 months ]

Original Secondary Outcome: Same as current

Information By: Cedars-Sinai Medical Center

Dates:
Date Received: October 31, 2007
Date Started: July 2007
Date Completion: December 2011
Last Updated: August 18, 2010
Last Verified: August 2010