This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter, investigator-initiated randomized study of long-acting octreotide (Sandostatin) alone vs. surgical debulking plus octreotide in acromegaly to determine if surgical debulking improves treatment effect. Data on currently available treatments (surgery, somatostatin analogs) are often difficult to compare, and no randomized trials have been completed. Subjects will be randomized to Arm A or B (1:2 ratio). Arm A begins with medical treatment alone: Patients are followed for 3 doses on Sandostatin. Arm B begins with surgical treatment alone. If after surgery the patient is not cured, the patient will go on Sandostatin for 3 doses (over 3 months). Endpoints are functional measures (IGF-I) and tumor size (MRI). The study may lead to a change in the initial management of patients, because surgery of macroadenomas of this sort is not initial treatment.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-45
Application #
7378336
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
45
Fiscal Year
2006
Total Cost
$6,079
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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