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临床试验/NCT03214419
NCT03214419已完成不适用

Anatobreast : First Step to Virtual Breast Cancer Localization

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Comparison of breast tumor localization obtained with the novel technique with the localization obtained with radioguided occult lesion localization

研究概览

简要总结

Radioisotopic and wire localizations suffer from several limitations. These techniques add another procedure prior to surgery, can be uncomfortable and entail additional cost.

The aim is to develop a novel technique of breast tumor localization using preoperative magnetic resonance imaging (MRI) and breast optical scanning.

Patients with diagnosis of breast cancer who have had a preoperative MRI and 3D optical scans are included.

Optical scanning is done preoperatively and intraoperatively after tumor localization was marked on the breast using radioisotopic technique.

The MRI is then adjusted with the intraoperative optical scan to match the breast position at the time of surgery.

The investigators evaluate the efficiency for localization of breast lesion of the novel technique by comparison with radiosiotopic technique.

详细描述

Breast cancer is the most commonly cancer diagnosed among women, with approximately 42000 women diagnosed with breast cancer annually in France. Incidence rates of breast cancer rose steadily from 1980 to 2005 due to the increasing use of screening mammography and longer life expectancy.

With advances in breast cancer screening techniques, many women now have malignant tumors detected before they become clinically palpable. For these women, breast conserving surgery (BCS) has become the preferred treatment option, comprising more than 75 % of surgeries in most breast cancer centers. The goal of BCS is to resect the tumor with a surrounding margin of tissue free of cancer while simultaneously preserving the overall shape and appearance of the breast. For non palpable lesions, localization of the tumor prior to surgery is needed. The standard technique for such patients is wire localization. Wire localization suffers from several limitations. It adds another procedure prior to surgery, complicating and lengthening the process. It can be uncomfortable for the patient and entails additional cost. This technique requires the surgeon to estimate the 3-dimensional (3D) position of the cancer from 2-dimensional mammography images. Wire localized excision results in positive margins approximately 30-50 % of the time. These cases require additional surgery to remove the remaining cancer, which is both costly and emotionally difficult for patients.

Alternatives to wire localization have been tested. Radioguided occult lesion localization (ROLL) has been shown to be superior to wire localization with shorter risk having positive resection margins and shorter duration of localization and surgical excision.

Magnetic resonance imaging of the breast has been shown to be more sensitive than ultrasound or mammography for the detection of cancer. Despite this evidence, the use of MRI has not been demonstrated to produce better short-term outcomes: the prospective randomized COMICE trial failed to demonstrate a decrease in the positive margin rate and need for re-excision with the use of preoperative prone MRI. The COMICE study authors recognized that the inability of prone MRI to result in decreased positive margin rates might be due to the way the imaging data is presented to the surgeon, stating that ''techniques to ensure surgical precision is at an optimum need further examination.'' The shape of the breast during prone MR imaging (with the breast pendant in a bilateral imaging coil) is radically different from the supine, arm-extended position in the operating room (OR). Supine MRI more accurately replicates the surgical position. Indeed, a study by Sakakibara et al. randomized patients with DCIS to undergo wire localized or supine MRI- guided BCS and found the positive margin rate and resected tissue volume were lower in patients undergoing supine MRI-guided excision.

The aim is to develop a novel technique of MRI- guided breast tumor localization that incorporates preoperative prone MRI and uses a preoperative and intraoperative 3D optical scans to adjust the MRI image to the exact position in the operating room. This novel technique will provide the surgeons with 3D views and measurements of tumor shape and position within the breast as it appears during surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Comparison of breast tumor localization obtained with the novel technique with the localization obtained with radioguided occult lesion localization

时间窗: The primary outcome measure will be done when the recruitment process will be completed, for an average of two months

The novel technique gives a 3D model and the localization of the tumor visible by transparency. The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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