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临床试验/NCT00223158
NCT00223158已完成不适用

L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial

Patrice Perron2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2003年9月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Evaluation of the hypothyroid status by the Billewicz questionnaire.

研究概览

简要总结

To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the time needed for TSH elevation (> 30 mUI/L) on placebo vs. L-T3.

详细描述

Patients with well differentiated thyroid cancer (DTC) need whole-body scintigraphy (WBS) and thyroglobulin (Tg) measurement in order to detect recurrence. Classically, withdrawal from levothyroxine (L-T4) during 4-6 weeks is needed for TSH elevation (> 30mUI/L), to allow iodine uptake and Tg production. As a result, patients become hypothyroid with impaired quality of life and a potential for tumour flare-up. Recombinant hTSH before WBS prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy. L-T3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients; however, no data exists to prove its benefit upon reducing hypothyroidism.

Objectives: 1) To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal. 2) To evaluate the time needed for TSH elevation (> 30 mUI/L) on placebo vs. L-T3.

Method: At the time of L-T4 withdrawal or after thyroidectomy, patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups (double-blind): L-T3 (50 mg qd) or an identical placebo for 3 weeks, after which treatment was stopped for 2 weeks. A validated questionnaire of signs and symptoms of hypothyroidism (Billewicz's scale) was administered every 2 weeks until the WBS. TSH, fT4 and fT3 were measured weekly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with well-differentiated thyroid cancer, with total thyroidectomy
  • 18 y.o. or older

排除标准

  • Use of rhTSH for Whole Body Scintigraphy preparation
  • Non stable cardiac arrythmias
  • Any condition impairing TSH elevation(glucocorticoid use, hypopituitarism)
  • Allergy to Liothyronine
  • Inability to give a consent

结局指标

主要结局

Evaluation of the hypothyroid status by the Billewicz questionnaire.

次要结局

  • The time to reach an acceptable TSH elevation.

研究者

发起方
Patrice Perron
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Patrice Perron

MD

Université de Sherbrooke

研究点 (2)

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