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Clinical Explorative Optical Breast Investigations

Clinical Explorative Optical Breast Investigations

Recruiting
18 years and older
Female
Phase N/A

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Overview

This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.

Description

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.

Eligibility

Inclusion Criteria:

  • solitary malignant or benign biopsy verified tumour > 1 cm
  • understands written and oral Swedish

Exclusion Criteria:

  • previous breast surgery
  • has received neoadjuvant chemotherapy
  • skin burns in on the chest

Study details
    Benign Breast Tumors
    Malignant Breast Tumours
    Healthy

NCT06857669

Region Skane

16 October 2025

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