SURGICAL DEBULKING OF PITUITARY ADENOMAS & RESPONSIVENESS TO OCTREOTIDE LAR

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。肢端肥大症是一种罕见但令人衰弱的疾病，由脑垂体瘤引起。目前的治疗选择极其有限。该方案将单纯的内科治疗与手术后内科治疗进行比较，以确定哪种方法对IGF-1控制最好，IGF-1是疾病活动性的关键指标。被诊断为肢端肥大症的成年受试者，如果计划接受垂体腺瘤切除手术，则可能符合条件。受试者将被随机分成两组中的一组。随机意味着偶然，就像抛硬币一样。第一组将把预定的手术推迟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。那些手术后继续表现出疾病活动的人将接受三个月的Sandostatin LAR治疗。善得定LAR(又称奥曲肽LAR)是美国食品和药物管理局(FDA)批准的一种药物。它类似于生长抑素，但比生长抑素更有效，生长抑素是一种自然产生的荷尔蒙，可以抑制脑下垂体释放生长激素(GH)。这项研究是为了找出手术是否有助于Sandostatin发挥作用，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、体检和患者评估以评估疾病活动性。用来确定垂体手术是否改善了对Sandostatin LAR的反应的主要指标是IGF-1的水平，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.