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Clinical Explorative Optical Breast Investigations

Breast Cancer Diagnosis Using Optical Techniques

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06857669
Acronym
CLEO-B
Enrollment
90
Registered
2025-03-04
Start date
2020-12-01
Completion date
2027-05-30
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Breast Tumors, Healthy, Malignant Breast Tumours

Keywords

breast, optical imaging, photoacoustic, spectroscopy

Brief summary

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

Detailed 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.

Interventions

DIAGNOSTIC_TESTDiffuse reflectance spectroscopy and Photoacoustic imaging,

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.

Sponsors

Region Skane
Lead SponsorOTHER
Lund University
CollaboratorOTHER
Unilabs
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of study subjects with correctly classified breast tissue type with PAI/DRS30 daysTo 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

MeasureTime frameDescription
Optical signal in relation to photoacoustic imaging depth2 daysSignal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.
To assess oxygenation levels across three breast tissue types using PAIImmediately after photoacoustic imaging acquisitionThe percentage of oxygenation within a region of interest (ROI)

Countries

Sweden

Contacts

CONTACTSophia Zackrisson, MD, PhD
sophia.zackrisson@med.lu.se+46 40 33 87 97
CONTACTNadia Chaudhry, MD
nadia.chaudhry@med.lu.se
PRINCIPAL_INVESTIGATORSophia Zackrisson, MD, PhD

Region Skane, Lund University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026