Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Differentiation between normal and malignant tissue
研究概览
简要总结
Investigation of application possibilities of optical spectroscopy within the field of oncology. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignancies.
详细描述
Primary Objective:
In this observational study the investigators aim to evaluate whether optical spectroscopy can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous interventions in lung, liver, and breast.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded. Analysis of this documentation will provide information for possible alterations of hardware design for improved clinical applicability in the future. Special attention will be paid to observe how the procedure fits in the standard workflow of the radiologist.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Patients with a suspicious lesion in lung or liver who are scheduled for a standard core biopsy procedure
- •Patient planned for percutaneous RFA of colorectal liver metastasis
- •Written informed consent
- •Patients ≥ 18 years old
- •Breast patients with a BIRADS score 4 or 5
- •General Exclusion criteria:
- •Patients who have higher risk of bleeding
- •Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
- •Breast Specific Exclusion criteria:
- •Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy
- •Patients who have breast implants
- •Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)
排除标准
- 未提供
结局指标
主要结局
Differentiation between normal and malignant tissue
时间窗: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations
次要结局
未报告次要终点