High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue.
研究概览
简要总结
This is a non-randomized, prospective phase II trial evaluating an innovative treatment, focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.
详细描述
Conservative Breast Treatment (BCT) :
The reference treatment for patients with stage T1 breast cancer is a partial mastectomy followed by radiotherapy (breast). This is a conservative treatment (BCT). Indeed, the survival results of this combined treatment are equivalent to those observed after a total mastectomy alone and is an aesthetically and psychologically more acceptable proposition for patients.
Adjuvant radiotherapy is an essential component of the success of conservative therapy most likely due to the impossibility of surgical treatment of removing all microscopically viable cancer cells. Indeed, in the absence of radiotherapy, partial mastectomy shows a local recurrence rate of 20-40% in case of N0 and 25-50% in case of N + on long-term follow-up data.
The results of the literature are very variable according to the length of the follow-up and the population studied but the adjuvant radiotherapy clearly allows to increase the rate of local control.
It reduces local recurrences to 10% at 12 years in the case of radiotherapy in the breast and 6% in case of boost on the tumor area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with invasive unifocal and unilateral noninflammatory ductal breast cancer.
- •Age> 18 years.
- •Size ≤ 10 mm (measured by MRI).
- •Histological confirmation of breast cancer by biopsy with sufficient material to estimate grade, hormonal status and HER2 status.
- •Lesion well delineated in MRI after injection of gadolinium and certain ultrasound correlation with the biopsy lesion.
- •Distance> 10 mm between the tumor and the skin and between the tumor and the muscle.
- •Performance status 0 or 1
- •Biological exam according to the following standards:
- •Neutrophiles> 1.5 x 109 / L Hemoglobin> 9 g / dL Plates> 100 x 109 / L ASAT - ALAT <2.5 x ULN Bilirubin <1.5 x ULN Creatinine <150 μmol / L and> 60 μmol / L Clearance> 30 ml / min
- •Informing the patient or her legal representative and signing the informed consent
- •Patient with Health care insurance available
排除标准
- •Invasive lobular carcinoma or extensive in-situ component or only presence of micro-calcifications as a disease sign
- •MRI or uncorrelated ultrasound lesion
- •Distance <10 mm between the tumor and the skin or nipple or chest cage or muscle
- •Patient weighing more than 110 Kg
- •Breast Implants
- •History of breast irradiation
- •History of surgery on the breast to be treated (fibrous scar, staples or surgical clips)
- •Treatment with antiaromatase, tamoxifen or neoadjuvant chemotherapy within 30 days of treatment start
- •History of severe cerebrovascular disease (cerebrovascular accident within 6 months prior to inclusion) or hemolytic anemia (hematocrite <30)
- •Patient with cardiac disorders (severe hypertension, antiarrhythmic treatments, history of cardiac ischemia) 1
- •Patient under dialysis
- •Patient under anti-coagulant treatment
- •Patient refusing surgery or for which surgery is contraindicated
- •Contraindication to the realization of MRI or thermo-ablation treatment
- •Patient has a contraindication to Gadolinium
- •Vulnerable persons are defined in Article L1121-5 to -8: Pregnant women, and nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons admitted without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions Of Article L. 1121-8 and persons admitted to a health or social institution for purposes other than research Persons of legal age who are under protection or who are unable to give their consent
结局指标
主要结局
Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue.
时间窗: up to 24 months
All surgical specimens will be collected and analyzed in full. The sterility of the surgical specimen will be assessed using the score proposed by the EORTC-STBSG (FUS-MRI) in the local treatment of infra-centimetric breast cancer by histological confrontation of the surgical specimen
次要结局
- Early skin toxicity is assessed until surgery(up to 24 months)
- The quality of life will be measured before treatment on D0, and during the visit between D21 and D28 using the QLQ-C30 questionnaire - breast module BR23-version 3.(up to 24 months)