Breast Cancer Diagnosis Using Optical Techniques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of study subjects with correctly classified breast tissue type with PAI/DRS
研究概览
简要总结
This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.
详细描述
Breast cancer is the most prevalent cancers among women worldwide. Current diagnostic modalities have notable limitations. Mammography exposes patients to harmful ionising radiation whilst MRI often requires intravenous contrast agents. Additionally, diagnosing breast cancer frequently relies on invasive biopsies, which can cause patient discomfort.
This study investigates the potential use of two optical modalities, diffuse reflectance spectroscopy (DRS) and photoacoustic imaging (PAI), as non-invasive diagnostic tools for breast tissue analysis. Advantages include use of non-ionising radiation, contrast-free imaging, and the ability to assess tissue properties in detail.
DRS is a non-image based hand-held modality that utilises white light to generate optical signals. PAI is a hybrid biomedical imaging modality that combines traditional ultrasound with optical imaging. The latter generates a functional image that can potentially assess oxygenation levels which is known to be different in healthy vs cancerous tissue.
The study will focus on analysing three types of human breast tissues: healthy tissue, benign lesions (such as fibroadenomas), and malignant lesions (invasive breast carcinomas). By identifying the unique optical signatures of each tissue type, the research aims to evaluate the feasibility of these optical techniques as complementary tool to traditional imaging methods for diagnosing or monitoring breast cancer in the future.
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
- 是
入选标准
- •solitary malignant or benign biopsy verified tumour > 1 cm
- •understands written and oral Swedish
排除标准
- •previous breast surgery
- •has received neoadjuvant chemotherapy
- •skin burns in on the chest
研究组 & 干预措施
Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)
In part I, 30 breast specimens will be examined by DRS (ex-vivo). In part II, 30 breast specimens will be examined by both DRS and PAI (ex-vivo). In part III, 30 individuals will be examined by PAI (in-vivo).
干预措施: Diffuse reflectance spectroscopy and Photoacoustic imaging, (Diagnostic Test)
结局指标
主要结局
Number of study subjects with correctly classified breast tissue type with PAI/DRS
时间窗: 30 days
To evaluate if optical techniques (DRS/PAI) can differentiate between three breast tissue types, namely healthy, benign and malignant tissue. Differences in the optical tissue-properties will be compared to histopathological evaluation.
次要结局
- To assess oxygenation levels across three breast tissue types using PAI(Immediately after photoacoustic imaging acquisition)
- Optical signal in relation to photoacoustic imaging depth(2 days)
