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临床试验/NCT03736564
NCT03736564已完成1 期

68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年1月31日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
18
试验地点
2
主要终点
Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)

研究概览

简要总结

The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.

详细描述

Subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. The first 10 patients that agree to participate in the study will be asked to present to the Mayo Clinic where they can provide a written consent and perform the imaging study.

Enrolled subjects will be evaluated in the clinical practice prior to having 68Ga-DOTATATE PET/CT imaging performed. The treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options.

Subjects will be follow for one year post 68Ga-DOTATATE PET/CT.

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

入选标准

  • Adults (18 years of age or older) seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study.

排除标准

  • Prisoners
  • Subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia
  • Subjects who do not consent for the study or withdraw consent during the duration of the study.
  • Subjects in whom tumor localization and successful resection has already occurred.

结局指标

主要结局

Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)

时间窗: One year

68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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