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NCT Number: NCT06857669

Clinical Explorative Optical Breast Investigations

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffuse reflectance spectroscopy and Photoacoustic imaging,

Diagnostic Test

The photoacoustic imaging/diffuse reflectance spectroscopy techniques used in this study have a broader wavelength spectrum. The photoacoustic set-up can generate an optical and an ultrasound image simultaneously.

Primary outcomes

  1. Number of study subjects with correctly classified breast tissue type with PAI/DRS

    Time frame: 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.

Secondary outcomes

  1. Optical signal in relation to photoacoustic imaging depth

    Time frame: 2 days

    Signal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.

  2. To assess oxygenation levels across three breast tissue types using PAI

    Time frame: Immediately after photoacoustic imaging acquisition

    The percentage of oxygenation within a region of interest (ROI)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Chaudhry, MD

CONTACT

[email protected]

Sophia Zackrisson, MD, PhD

CONTACT

[email protected]

+46 40 33 87 97

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University
  • Unilabs

Registry information

Official study title

Breast Cancer Diagnosis Using Optical Techniques

Acronym: CLEO-B

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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