CTIS2024-513251-32-00进行中（未招募）1 期
Role of contrast enhanced mammography with Iomeprol 400 mgI/ml (Iomeron, Bracco), in the identification of breast cancer: I3-MaC Study - I3-MaC Study
Azienda Ospedaliero-Universitaria Policlinico Umberto I0 个研究点目标入组 173 人开始时间: 2024年3月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 173
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Female patients = 35 years of age • Patients who underwent mammography during the 5 weeks prior to enrollment in the study • Patients with a breast lesion requiring further assessment with biopsy ? BIRADS 4 or 5 breast lesion seen at mammography ? Suspicion of malignancy of a lesion seen at ultrasound and not evaluable with mammography • Patients who provide their written informed consent and are willing to comply with protocol requirements
排除标准
- •Renal insufficiency (eGFR below 30 mL/min using the MDRD equation [MDRD=Modification of Diet in Renal Disease]) • Allergy to iodinated contrast agents • BRCA 1 or 2 mutation • Pregnant or lactating females; subjects in post-partum • Severe hypertension (systolic blood pressure >100 under treatment or uncontrolled hypertension with systolic pressure >160 and/or diastolic pressure >90)
研究者
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