Clinical Explorative Optical Breast Investigations (CLEO-B)

Region Skane

Status: Enrolling

Conditions: Healthy; Malignant Breast Tumours; Benign Breast Tumors

Treatments: Diagnostic Test: Diffuse reflectance spectroscopy and Photoacoustic imaging,

Study type: Interventional

Funder types: Other

Identifiers

NCT06857669

Dnr 2019-04840

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Diffuse reflectance spectroscopy and Photoacoustic imaging,