Clinical trial NCT06857669: Clinical Explorative Optical Breast Investigations
Official title: Breast Cancer Diagnosis Using Optical Techniques
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Breast Tumors
Malignant Breast Tumours
Healthy
Keywords: breast
optical imaging
photoacoustic
spectroscopy
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Unilabs
First posted: 2025-03-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of study subjects with correctly classified breast tissue type with PAI/DRS
timeFrame: 30 days
Secondary outcomes:
measure: Optical signal in relation to photoacoustic imaging depth
timeFrame: 2 days
measure: To assess oxygenation levels across three breast tissue types using PAI
timeFrame: Immediately after photoacoustic imaging acquisition
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Region Skane, Lund University
name: Sophia Zackrisson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaudhry N, Albinsson J, Cinthio M, Kroll S, Malmsjo M, Ryden L, Sheikh R, Reistad N, Zackrisson S. Breast Cancer Diagnosis Using Extended-Wavelength-Diffuse Reflectance Spectroscopy (EW-DRS)-Proof of Concept in Ex Vivo Breast Specimens Using Machine Learning. Diagnostics (Basel). 2023 Sep 28;13(19):3076. doi: 10.3390/diagnostics13193076.