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临床试验/NCT06857669
NCT06857669招募中不适用

Breast Cancer Diagnosis Using Optical Techniques

Region Skane1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

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)

Experimental

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)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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