NCT07459062招募中不适用
Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.
SPCTR2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens
研究概览
简要总结
This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients. By collecting spectral biomarkers and correlating these with the golden standard of histopathological assessment by a pathologist, we aim to train and optimize an AI model that is able to achieve the following outcomes with classifying tissues:
- Sensitivity (percentage of classified positive margins of actual positive margins): ≥ 96% CI 95.5-97.5%
- Specificity (percentage of classified free margins of actual free margins): 96% CI 95.5-97.5%
- Accuracy (total correctly classified margins): ≥ 96% CI 95.5-97.5%
- Negative predictive value (amount of true negative - free margins - among the classified negative margins): ≥ 95% CI 94.5-96.5%
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed diagnosis breast cancer for which surgical procedure is needed
- •Planned for breast conserving surgery
排除标准
- •Person that undergoes breast amputation without confirmed cancer diagnosis
研究组 & 干预措施
Breadloaf slices
Only sliced specimen are scanned during phase 1
Whole specimen & Breadloaf slices
Whole specimen and sliced specimen are scanned during phase 2
结局指标
主要结局
Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens
时间窗: Through study completion, an average of 6 months
Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.
次要结局
未报告次要终点
研究者
研究点 (2)
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