SURGICAL DEBULKING OF PITUITARY ADENOMAS & RESPONSIVENESS TO OCTREOTIDE LAR

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 肢端肥大症是一种罕见但使人衰弱的疾病，由垂体瘤引起。 目前的治疗选择非常有限。 该方案将单独的药物治疗与手术治疗进行比较，以确定哪种方法最好地控制IGF-1，这是疾病活动的关键指标。 计划接受垂体腺瘤减瘤手术的肢端肥大症诊断成人受试者可能有资格。 受试者将被随机分配至两组之一。 随机意味着偶然，就像抛硬币一样。 第一组将推迟预定的手术3个月，并在此期间接受FDA批准的药物Sandostatin LAR的治疗。 第二组将立即接受手术。 那些在手术后继续显示疾病活动的人将接受为期三个月的Sandostatin LAR治疗。 Sandostatin LAR（也称为Octreotide LAR）是美国食品和药物管理局（FDA）批准的药物。 它类似于生长抑素，但比生长抑素更有效，生长抑素是一种天然存在的激素，抑制垂体释放生长激素（GH）。 这项研究是为了找出手术是否有助于善得定的工作，以改善肢端肥大症患者的治疗选择。 研究程序包括MRI、EKG、OGTT、抽血、体格检查和患者评估以评估疾病活动。 用于确定垂体手术是否改善善得定LAR反应的主要指标是IGF-1水平，IGF-1是肢端肥大症活动的重要指标。'

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. Acromegaly is a rare but debilitating disease caused by a pituitary tumor. Current therapeutic options are extremely limited. This protocol compares medical treatment alone to surgery followed by medical treatment to determine which method best controls IGF-1, a key indicator of disease activity. Adult subjects with a diagnosis of acromegaly who are scheduled to receive pituitary adenoma debulking surgery may be eligible. Subjects will be randomized into one of two arms. Randomly means by chance, like flipping a coin. The first group will delay scheduled surgery for 3 months and receive medical treatment with FDA-approved medication Sandostatin LAR during that time. The second group will receive surgery immediately. Those who continue to show disease activity after surgery will then receive medical treatment with Sandostatin LAR for three months. Sandostatin LAR (also called Octreotide LAR) is a medication approved by the Food and Drug Administration (FDA). It is similar to, but more effective than somatostatin, which is a naturally occurring hormone that inhibits the release of growth hormone (GH) from the pituitary gland. This study is being done to find out if surgery helps Sandostatin work, to improve treatment options for people with acromegaly. Study procedures include MRI, EKG, OGTT, blood draws, physical examination, and patient assessments to evaluate disease activity. The primary measure used to determine whether pituitary surgery improves the response to Sandostatin LAR is levels of IGF-1, a substance that is an important indicator of acromegaly disease activity.'