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临床试验/NCT02843542
NCT02843542Unknown不适用

Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study

Assuta Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Adenomas size and location

研究概览

简要总结

A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients.

详细描述

Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. in addition to the conservative 99mTc-MIBI (methoxyisobutylisonitrile) and US, patients will also undergo 18FCH (¹⁸F-choline) PET/MRI for detecting adenomas and their location. imaging experts will decode the imaging exams. sensitivity and specificity of the exams will be examined.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the criteria accepted in the World Health Organization (WHO) analysis:
  • Symptomatic patients (constipation, depression, peptic ulcer, pathologic fractures, chronic fatigue, pain from a urinary tract stones etc..)
  • or at least one of the following criteria:
  • Blood calcium levels above 1 more than normal
  • Creatinine clearance decreased in 30% from age expected
  • Urine Creatinine above 400 mg in 24 hours

排除标准

  • Patients with hyperthyroidism secondary and tertiary (secondary to kidney disease)
  • Patients who are not eligible to sign an informed consent
  • Pregnant women
  • Patients with sensitivity (allergy) technetium or 18FCH

结局指标

主要结局

Adenomas size and location

时间窗: 24 months

Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).

次要结局

  • Parathyroid hormone levels(24 months)
  • Disease related medication consumption(24 months)
  • Chronic disease duration(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Avi Hefetz

MD

Assuta Medical Center

研究点 (1)

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