Studies of Benign and Malignant Thyroid Disease

良性和恶性甲状腺疾病的研究

• 批准号: 8940184
• 负责人: Monica Skarulis
• 金额: $ 39.28万
• 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/8940184
• 关键词: Ablation; Adjuvant; Age; Benign; Biological; Blood; Blood specimen; Chloride Ion; Chlorides; Clinical; Clinical Data; Clinical Research; Clinical Trials; Code; Consensus; Detection; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Dose; Enzymes; Epidemiologic Studies; Excision; Exposure to; Follicular thyroid carcinoma; Future; Goals; Hormones; Hour; Human; I131 isotope; Individual; Lead; Ligands; Lithium; Lithium Carbonate; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of thyroid; Measurement; Methods; Monitor; Moods; Natural History; Nature; Neoplasms; Nodule; Operative Surgical Procedures; Orthostatic Hypotension; Palpable; Papillary Carcinoma; Patient Participation; Patients; Phase III Clinical Trials; Placebos; Positron-Emission Tomography; Preparation; Protocols documentation; Radiation; Radioactive Iodine; Radiopharmaceuticals; Randomized Controlled Clinical Trials; Recombinants; Recruitment Activity; Recurrence; Reporting; Residual Tumors; Risk; Sampling; Serum; Specimen; Staging; Symptoms; Technetium Tc 99m Sestamibi; Techniques; Testing; Therapeutic; Thyroglobulin; Thyroid Diseases; Thyroid Gland; Thyroid Hormones; Thyroid Nodule; Thyroid carcinoma; Thyrotropin-Releasing Hormone; Time; Tissues; Tracer; Uncontrolled Study; United States National Institutes of Health; Withdrawal; Woman; cell type; experience; fluorodeoxyglucose positron emission tomography; follow-up; improved; men; mortality; neoplasm registry; outcome forecast; pentetreotide; prospective; research study; residence; response; risk benefit ratio; standard care; thyroid neoplasm; tumor; uptake; whole body imaging

Patients of all ages are actively recruited to this natural history protocol in which methods for follow-up of patients using radiopharmaceutical tracers such as I-131, I-123, 201Tl chloride, 99mTc-Sestamibi, 111In-pentetreotide, 18-FDG PET and other PET ligands are 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 are 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. Recruitment to this study in now complete. 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.

所有年龄段的患者都被积极招募到这种自然历史方案中，其中使用放射性药物示踪剂进行随访的方法，例如I-131，I-123，201TL氯化物，99mtc-Sestamibi，111in-pentetreotide，18-FDG PET，18-FDG PET和其他宠物配体。 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，碳酸锂或安慰剂对甲状腺残留疗法成功消融率的影响。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。现在完成这项研究的招聘。 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。