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Spots Global Cancer Trial Database for A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

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Trial Identification

Brief Title: A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

Official Title: 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

Study ID: NCT01861717

Conditions

Acromegaly

Interventions

lanreotide

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System, Santa Monica, California, United States

Contact Details

Name: Daniel F Kelly, MD

Affiliation: Saint John's Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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