HISMAR: A Prospective Post-Market Performance Follow-up Study of the Histolog Scanner for Intraoperative Margin Assessment in Breast-Conserving Surgery for High-Risk Histological Subtypes (ILC, DCIS, NST+DCIS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Reoperation Rate
研究概览
简要总结
This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS).
After lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing.
Based on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.
详细描述
BACKGROUND Breast cancer is the most common cancer in women in Switzerland, with approximately 6,500 new cases annually. Breast-conserving surgery (BCS, lumpectomy) is the preferred surgical approach for localised tumours and achieves equivalent survival outcomes to mastectomy when negative margins are obtained. However, re-excision rates of 20-30% have been reported in unselected BCS populations.
The risk of positive margins is particularly elevated in specific histological subtypes: published data indicate a relative risk of positive margins of 2.21 for ductal carcinoma in situ (DCIS) and 1.44 for invasive lobular carcinoma (ILC) compared to NST carcinoma without in situ component. A retrospective analysis of 266 consecutive eligible BCS cases at CHVR (2021-2024) identified a reoperation rate of 11.3% (30/266). A prospective study in the literature reported a reduction from 30% to 10% when intraoperative histological scanning was added to standard of care.
DEVICE The Histolog® Scanner (SamanTree Medical SA, Lausanne; CE IVD Class A, UDI 764017998003GV, software v3.4.0) enables real-time confocal fluorescence imaging of fresh lumpectomy specimen surfaces ex vivo, without tissue processing or staining, providing H&E-quality images intraoperatively. The device is already in routine clinical use at CHVR.
STUDY OBJECTIVE To evaluate whether systematic use of the Histolog® Scanner in addition to standard of care reduces the reoperation rate by 50% or more - from 11.3% to ≤5.6% - in patients with ILC, pure DCIS, or NST+DCIS undergoing BCS at CHVR.
STUDY DESIGN Prospective, single-arm, single-centre post-market performance follow-up (PMPF) study (IVDR 2017/746). Comparator: validated historical institutional control (CHVR 2021-2024, same surgical team, n=266, reoperation rate 11.3%). A randomised design was not ethically justifiable as the device is already in routine use at CHVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient, aged 18 years or older at time of surgery.
- •Pre-operative core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) with histological diagnosis of one of the following:
- •invasive lobular carcinoma (ILC/CLI),
- •pure ductal carcinoma in situ (DCIS), or
- •invasive carcinoma of non-special type (NST) with an associated DCIS component.
- •Planned breast-conserving surgery (BCS / lumpectomy) at CHVR.
- •Signed electronic informed consent (eIC) obtained prior to any study procedure.
排除标准
- •Pregnancy (confirmed or suspected) at time of surgery.
- •Prior neo-adjuvant treatment (hormonal therapy or chemotherapy) for the current breast cancer diagnosis.
- •Surgical indication for mastectomy rather than BCS.
- •Known hypersensitivity or allergy to acriflavine (fluorescent staining agent used with the Histolog Scanner).
- •Incapacity to provide informed consent.
- •Previous enrolment in this study.
研究组 & 干预措施
Histolog® Scanner + Standard of Care
Patients undergo breast-conserving surgery (BCS) with systematic intraoperative margin assessment using the Histolog® Scanner in addition to standard of care (palpation, specimen radiography at surgeon's discretion). Intraoperative recuts are decided based on combined standard of care and Histolog® Scanner findings. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology, independently of intraoperative findings.
干预措施: Histolog® Scanner (Device)
结局指标
主要结局
Reoperation Rate
时间窗: Within 4 weeks after breast-conserving surgery
Proportion of enrolled patients for whom the multidisciplinary tumour board recommends re-excision surgery following definitive histopathological analysis of the lumpectomy specimen. The outcome is binary (reoperation: yes/no). Compared against the historical institutional control rate of 11.3% (CHVR 2021-2024, n=266).
次要结局
- Reoperation rate(Within 4 weeks after breast-conserving surgery)
- Intraoperative recut rate(Intraoperative)
- Cost analysis(At study completion, approximately 3.5 years)
- Concordance between intraoperative and final pathological margin assessment(Within 4 weeks after breast-conserving surgery)