NCT04347135撤回1 期
Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Annie (Annie) T. Packard1 个研究点 分布在 1 个国家开始时间: 2022年10月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Detection of Endometriosis
研究概览
简要总结
Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women (18-50) with endometriosis
排除标准
- •Postmenopausal women
- •AP diameter when lying supine greater than 32 cm (too large for PET/MRI)
- •Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)
- •Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy)
- •Pregnant (Urine test will be provided for all patients)
研究组 & 干预措施
F-18 FES PET/MRI
Experimental
16α-(18)F-fluoro-17β-estradiol ([F-18] FES)
干预措施: F-18 FES (Drug)
结局指标
主要结局
Detection of Endometriosis
时间窗: 24 months
Comparisons will be made descriptively between conventional MRI imaging, FES PET/MRI imaging and surgical/pathologic findings. Outcome data include number of detected lesions, differences in the accuracy for detection of active disease versus inactive fibrosis, and confidence score.
次要结局
未报告次要终点
研究者
Annie (Annie) T. Packard
Principal Investigator
Mayo Clinic
研究点 (1)
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