Studies of Thyroid Function and Growth in Health and Dis

甲状腺功能和健康与疾病生长的研究

• 批准号: 7337595
• 负责人: Monica Skarulis
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7337595
• 关键词: Studies; Thyroid; Function; Growth; Health

The project goal is the evaluation and treatment of thyroid disorders. Patients with thyroid function abnormalities (hyperthyroidism, hypothyroidism) are enrolled. Patients undergo routine history and physical examination, standard endocrine blood and urine tests, a standard TRH test (using a preparation under IND), thyroid nuclear medicine scans, thyroidal radioiodine (RAI) or technetium (99mTc) uptake measurements, as well as X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) studies or other standard diagnostic procedures, as clinically indicated. Patients are screened for entry into other research studies including the effects of thyroid hormone on the cytochrome p450 and p-glycoprotein activity. Another area of study is the methods for preoperative diagnosis and therapy of thyroid cancer. Study subjects include adults and children with thyroid nodules or cancer requiring diagnostic fine needle aspiration biopsy, surgery, radioiodine scanning or therapy for persistent or recurrent disease. In this natural history protocol, the use of methods for follow-up of patients using radiopharmaceutical tracers such as I-131, I-123, 201Tl chloride, 99mTc-Sestamibi, 111In-pentetreotide and 18-FDG PET will be evaluated. The limitations and significance of serum thyroglobulin (Tg) measurement for diagnosing tumor recurrence are assessed as is the risk/benefit ratio of already established methods of administering I-131 therapy including the impact of pre-treatment dosimetric calculations and administration of adjuvants such as recombinant human TSH and lithium. The use of radioactive iodine in the treatment of patients with stage I or II thyroid cancer who are at low risk for mortality is controversial. In a randomized, controlled clinical trial, the effects of lithium carbonate or placebo on the rate of successful ablation of thyroid remnant will be asssessed. By increasing the biological half-time of I-131 through its effects on thyroid hormone release, it is hypothesized that adjuvant lithium administration will improve the efficacy of low dose radiodine (30 mCi). The goal is to obtain satisfactory ablation of thyroid with minimum radiation exposure. The study will recruit 100 low risk patients over the age of 16 years with differentiated, non-medullary thyroid cancer. Samples of benign nodules and cancer tissue specimens for research studies will be collected to assess new immunohistochemical markers, and other techniques to characterize tumors for correlation with response to therapy and prognosis. Blood specimens are collected for future clinical and research studies in both the hypothyroid and euthyroid state. Coded clinical data are entered in the National Thyroid Cancer Registry in selected patients. This study also serves to screen patients for participation in other protocols.

项目目标是甲状腺疾病的评估和治疗。患有甲状腺功能异常（甲状腺功能亢进，甲状腺功能减退症）的患者已招募。患者接受常规病史和体格检查，标准内分泌血液和尿液测试，标准TRH测试（使用IND下的制剂），甲状腺核医学扫描，甲状腺放射性碘（RAI）或Technetium（99MTC）（99MTC）的摄取测量值以及X射线仪（X射线学（CT）或磁性调查（CT）或其他标准符号（MRI）或其他标准符号（MRI）或其他标准图像。将患者筛查进行其他研究，包括甲状腺激素对细胞色素P450和P-糖蛋白活性的影响。 研究的另一个领域是甲状腺癌术前诊断和治疗的方法。研究对象包括成人和患有甲状腺结节的儿童或癌症，需要诊断精细的针刺活检，手术，放射性碘扫描或治疗持续性或复发性疾病。 在这种自然历史方案中，将评估使用使用放射性药物示踪剂（例如I-131，I-123、201TL氯化物，99mtc-Sestamibi，111in-pentetreotide和18-FDG PET）进行随访的方法。评估了诊断肿瘤复发的血清甲状腺球蛋白（TG）测量的局限性和意义，以及已经确定的管理I-131治疗方法的风险/福利比，包括治疗前的剂量计算和给药的影响，例如重组的人类TSH和Lithium。 在患有低死亡风险的I期或II期甲状腺癌患者中使用放射性碘是有争议的。在一项随机，对照临床试验中，碳酸锂或安慰剂对成功消融甲状腺残余的速度的影响将被评估。通过通过对甲状腺激素释放的影响增加I-131的生物半个时间，可以假设锂给药将提高低剂量radiodine（30 MCI）的疗效。目的是获得最小辐射暴露的甲状腺令人满意的消融。这项研究将在16岁以上招募100名低风险患者，并通过分化的非优质甲状腺癌招募。 将收集良性结节和癌症组织样品的样品，以评估新的免疫组织化学标记，以及其他技术来表征肿瘤与治疗和预后的反应相关的肿瘤。收集血液标本以用于甲状腺功能减退症和甲状腺甲状腺状态的未来临床和研究。在选定患者的国家甲状腺癌注册表中输入了编码的临床数据。这项研究还可以筛查患者参加其他方案。