SURGICAL DEBULKING OF PITUITARY ADENOMAS & RESPONSIVENESS TO OCTREOTIDE LAR

垂体腺瘤手术切除

• 批准号: 7376572
• 负责人: WILLIAM F CHANDLER
• 金额: $ 0.97万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376572
• 关键词: octreotide; somatostatin; surgery

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。肢端肥大症是一种罕见但使人衰弱的疾病，由垂体肿瘤引起。目前的治疗方法非常有限。该方案比较了单独的药物治疗和手术后的药物治疗，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。诊断为肢端肥大症的成人受试者计划接受垂体腺瘤减容手术可能符合条件。受试者将被随机分为两组。随机的意思是偶然的，就像抛硬币一样。第一组将推迟计划手术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。那些在手术后仍有疾病活动的患者将接受三个月的山多他汀LAR药物治疗。山多他汀LAR（也称为奥曲肽LAR）是美国食品和药物管理局（FDA）批准的一种药物。它与生长抑素相似，但比生长抑素更有效，生长抑素是一种自然产生的激素，可以抑制脑垂体释放生长激素（GH）。这项研究是为了发现手术是否能帮助山多司他汀发挥作用，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、体格检查和患者评估以评估疾病活动性。用于确定垂体手术是否改善对Sandostatin LAR的反应的主要措施是IGF-1水平，这种物质是肢端肥大症疾病活动的重要指标。