A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Free-surgical margins
研究概览
简要总结
Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-palpable breast lesions;
- •Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
- •Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);
- •Written informed consent.
排除标准
- •Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);
- •Clinically palpable breast lesion;
- •Breast lesion localization for planned neoadjuvant chemotherapy.
结局指标
主要结局
Free-surgical margins
时间窗: 3 years
Number of surgical procedures in which surgical margins are disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
次要结局
- Surgery Time(3 years)
- Hospitalization days(3 years)
- Complications(3 years)
- Excess breast resection(3 years)
- Cost-effectiveness analysis(3 years)
- Reintervention(3 years)
- Follow up(5 years after enrollment)
研究者
Fabio Corsi
Professor
Istituti Clinici Scientifici Maugeri SpA