2024-517486-16-00招募中2 期
The role of Contrast-Enhanced Spectral Mammography (CESM) in the diagnostic process of breast cancer: can it improve specificity of first-line examinations and therefore reduce the suspicious lesions that undergo vacuum assisted breast biopsy (VABB)?
Istituto Europeo Di Oncologia S.r.l., Istituto Europeo Di Oncologia S.r.l.1 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2024年10月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)
研究概览
简要总结
To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended. Only women in the BI-RADS 4 radiological category risk will be included in the study.
- •The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations. Only patients with ECOG scale 0 or 1 performance status will be included in the study.
- •Only patients with an age > or = to 18 can be included in the study.
排除标准
- •The subject is known to have risks of adverse effects with iodine contrast agents.
- •Patients with a clinical examination positive for regional lymph nodes or suspected for distant metastases (bones, brain, liver and lungs).
- •The subject is asymptomatic and without suspicious findings from routine imaging.
- •The subject is participating or has participated (within the prior 30 days) in another clinical trial.
- •Proved or supposed pregnancy. For all women of child bearing potential a pregnancy test will be performed before undergoing CESM.
- •Patients with impairment of renal function (GFR < 30 ml/min).
- •History of bronchial asthma or other allergic disorders.
- •Manifest hyperthyroidism. Testing of thyroid function prior to Ultravist® administration will be performed in patients with suspected hyperthyroidism.
- •Patients with risk of serious adverse reactions such as cardiac disease, heart failure, uncontrolled arterial hypertension.
- •Patients in therapy with biguanide such as metformin, interleukine 2 and radioactive iodine.
结局指标
主要结局
To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)
To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)
次要结局
- To establish CESM diagnostic performance in suspicious breast lesions using histology from VABB as gold standard correlating the definite result (after surgery) with preoperative imaging (accuracy).
研究者
Enrico Cassano
Scientific
Istituto Europeo Di Oncologia S.r.l.
研究点 (1)
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