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.

该项目的目标是评估和治疗甲状腺疾病。甲状腺功能异常（甲状腺功能亢进、甲状腺功能减退）的患者入组。患者接受常规病史和体格检查、标准内分泌血液和尿液检查、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) 或锝 (99mTc) 摄取测量以及 X-根据临床指示，进行射线、计算机断层扫描 (CT) 或磁共振成像 (MRI) 研究或其他标准诊断程序。患者需要接受其他研究的筛选，包括甲状腺激素对细胞色素 p450 和 p-糖蛋白活性的影响。 另一个研究领域是甲状腺癌的术前诊断和治疗方法。研究对象包括患有甲状腺结节或癌症的成人和儿童，需要进行诊断性细针抽吸活检、手术、放射性碘扫描或治疗持续性或复发性疾病。 在此自然史方案中，将评估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）随访患者的方法的使用。评估血清甲状腺球蛋白 (Tg) 测量诊断肿瘤复发的局限性和意义，以及已建立的 I-131 治疗方法的风险/效益比，包括治疗前剂量计算和重组等佐剂给药的影响人类 TSH 和锂。 使用放射性碘治疗死亡风险较低的 I 期或 II 期甲状腺癌患者存在争议。在一项随机对照临床试验中，将评估碳酸锂或安慰剂对残余甲状腺消融成功率的影响。通过影响甲状腺激素释放来增加 I-131 的生物半衰期，推测辅助锂给药将提高低剂量放射性 (30 mCi) 的疗效。目标是以最小的辐射暴露获得令人满意的甲状腺消融。该研究将招募 100 名 16 岁以上患有分化型非髓样甲状腺癌的低风险患者。 将收集用于研究的良性结节和癌症组织标本样本，以评估新的免疫组织化学标记物和其他技术来表征肿瘤与治疗反应和预后的相关性。收集血液样本用于未来甲状腺功能减退和甲状腺功能正常状态下的临床和研究。选定患者的编码临床数据被输入国家甲状腺癌登记处。这项研究还用于筛选患者是否参与其他方案。