NCT03935984Unknown4 期
Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan With Calcitonin Pre-treatment for Primary Hyperparathyroidism
ProMedica Health System1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年5月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Sensitivity of SPECT-CT
研究概览
简要总结
Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary hyperparathyroidism
- •Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study
- •Patient desires surgical intervention for treatment of PHPT
- •No contraindications to 99mTC-Sestamibi
- •No contraindications to treatment with calcitonin
- •Serum calcium level prior to non-localizing SPECT-CT is ≥10.5 mg/dL
- •Patient consents to participate and undergo second SPECT-CT for purposes of research
排除标准
- •Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary
- •Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT
- •Allergy to calcitonin
- •Hypocalcemia (contraindication to calcitonin)
- •Vitamin D deficiency (contraindication to calcitonin)
- •Previous treatment with radioactive iodine
- •New prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan)
- •Lithium exposure within one year of SPECT-CT (index and research scans)
- •Secondary hyperparathyroidism
- •Benign familial hypocalciuric hypercalcemia
- •Known malignancy, particularly multiple endocrine neoplasia
- •New prescription of thiazide diuretic, (thiazide diuretic must have been taken at the time of index scan and second scan)
- •Currently taking calcium channel blockers
- •Pregnancy
研究组 & 干预措施
Treatment Group
Experimental
All subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging
干预措施: Calcitonin (Drug)
结局指标
主要结局
Sensitivity of SPECT-CT
时间窗: one year
conversion rate from non-localizing to localizing exam
次要结局
- Surgical Approach(6 months)
- Success Rate(6 months from surgery)
研究者
Juan Jaume
Principal Investigator
ProMedica Health System
研究点 (1)
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