Ultrasound Guided Sandostatin LAR Injection in Acromegaly

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acromegaly	Drug: Sandostatin LAR	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly
Study Start Date :	July 2007
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
1; 3 months of ultrasound guided IM injections of octreotide LAR followed by 3 months of non-ultrasound guided injections of octreotide LAR	Drug: Sandostatin LAR; use of consistent monthly dose of medication for duration of 6 months.; Other Name: Ultrasound guided Sandostatin LAR injection Drug: Sandostatin LAR; All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.
2; 3 months of non-ultrasound guided octreotide LAR IM injections followed by ultrasound guided IM injections of LAR	Drug: Sandostatin LAR; All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male and female patients ≥18 years old
• Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.
• Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.
• Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects
• Patients have provided written informed consent

Exclusion Criteria:

• Uncontrolled diabetes mellitus
• Patients who are pregnant or lactating
• Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound
• Patients with current gallstones
• Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
• Patients with a history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
• Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy
• Patients who have received other investigational drugs administered or received within 30 days of study entry
• Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment

Contacts and Locations

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Contacts

Contact: Billy Gellepis	(310) 423-3395	gellepisw@cshs.org
Contact: Lori Korsakoff, RN, BSN	(310) 423-2411	korsakoffl@cshs.org

Locations

United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John D Carmichael, MD
Sub-Investigator: Shlomo Melmed, MD
Sub-Investigator: Vivien Bonert, MD

Sponsors and Collaborators

Cedars-Sinai Medical Center

Novartis Pharmaceuticals

Investigators

Principal Investigator:	John D Carmichael, MD	Cedars-Sinai Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	John Carmichael, MD, Cedars-Sinai Medical Center, Pituitary Center
ClinicalTrials.gov Identifier:	NCT00552071 History of Changes
Other Study ID Numbers:	11482; CSMS995BUS60
First Posted:	November 1, 2007
Last Update Posted:	August 19, 2010
Last Verified:	August 2010

Keywords provided by Cedars-Sinai Medical Center:

Acromegaly; Octreotide LAR; Ultrasound guidance

Additional relevant MeSH terms:

Acromegaly; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Octreotide; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents