NCT02834494已完成不适用
3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
研究概览
简要总结
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy in patients with locally advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Infiltrating Breast Cancer untreated and/or locally advanced (stages I (T1c), IIa IIb, IIIa, IIIb, IIIc of UICC classification), whatever histological type.
- •Neo-adjuvant chemotherapy decided.(Anthracyclines, taxanes and, for tumors overexpressing human epidermal growth factor receptor 2 (HER2) protein, targeted recombinant humanized monoclonal antibodies)
- •Index tumor whose dimensions are between 10 to 50 mm. Multifocality, and/or multicentricity and/or bilaterality accepted (maximum 2 tumors by breast et tumors well differentiated from each other).
- •Patients aged at least 18 years old at diagnosis
- •Full results conventional breast exams available and no reason to achieve MRI breast exam
- •Patient explanation given and consent information signed
排除标准
- •Pregnant or during lactation
- •Personal history of ipsilateral breast cancer (ipsilateral recurrence or second cancer in the same breast).
- •Patient carrier of cosmetic breast implants
- •Person deprived of liberty or under guardianship
- •Contraindication for receiving neo-adjuvant chemotherapy for any medical reason
- •Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
研究组 & 干预措施
3D Shear Wave Elastography (SWE)
Other
干预措施: 3D Shear Wave Elastography (SWE) (Procedure)
3D Shear Wave Elastography (SWE)
Other
干预措施: Biopsy (Biological)
结局指标
主要结局
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
时间窗: up to 32 months
Measure of the tumor prior to neoadjuvant chemotherapy (T0), at T1 and T2(1stand 2nd courses of anthracycline), at mid-treatment between anthracycline and taxane chemotherapy (Tmi), at the end of chemotherapy before surgery (Tfin).
次要结局
- tumor volume changes under treatment by 3D ultrasound(up to 32 months)
- Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine(up to 32 months)
- Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)(up to 32 months)
- Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).(up to 32 months)
- Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score(up to 32 months)
- Compare tumor elasticity to conventional histological parameters(6 weeks)
- Reliable early biomarker of histological response.(up to 32 months)
- peritumoral environmental elasticity properties(up to 32 months)
- Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity(up to 32 months)
- Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"(up to 32 months)
研究者
研究点 (1)
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