Clinical Explorative Optical Breast Investigations

Last updated: March 5, 2025
Sponsor: Region Skane
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Diffuse reflectance spectroscopy and Photoacoustic imaging,

Clinical Study ID

NCT06857669
Dnr 2019-04840
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • solitary malignant or benign biopsy verified tumour > 1 cm

  • understands written and oral Swedish

Exclusion

Exclusion Criteria:

  • previous breast surgery

  • has received neoadjuvant chemotherapy

  • skin burns in on the chest

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Diffuse reflectance spectroscopy and Photoacoustic imaging,
Phase:
Study Start date:
December 01, 2020
Estimated Completion Date:
May 30, 2027

Study 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.

Connect with a study center

  • Skane University Hospital

    Malmo, 20502
    Sweden

    Active - Recruiting

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