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临床试验/NCT03549598
NCT03549598已完成4 期

d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
15
试验地点
1
主要终点
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)

研究概览

简要总结

The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.

详细描述

Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.

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

  • 18 years of age or older
  • Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

排除标准

  • Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan

研究组 & 干预措施

68Ga-DOTATATE PET/CT

Experimental

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject

干预措施: 68Ga-DOTATATE PET/CT (Drug)

68Ga-DOTATATE PET/CT

Experimental

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject

干预措施: 18FDG PET/CT scan (Drug)

68Ga-DOTATATE PET/CT

Experimental

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject

干预措施: 13NH3 PET/CT scan (Drug)

结局指标

主要结局

68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)

时间窗: 3 days

The number of subjects with areas of abnormal myocardial increased focal uptake

18FDG Uptake With Cardia Sarcoidosis (CS)

时间窗: 2 days

The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan

13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)

时间窗: 2 days

The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan

次要结局

  • Physician Confidence in Study Interpretation(2 days)
  • Subject Satisfaction(2 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

John P. Bois, M.D.

Assistant Professor of Medicine

Mayo Clinic

研究点 (1)

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