Skane University Hospital
Malmö, 20502, Sweden
Location status: Recruiting
Location contact
Nadia Chaudhry, MD
CONTACT
Sophia Zackrisson, MD, PhD
CONTACT
NCT Number: NCT06857669
This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Malmö, 20502, Sweden
Location status: Recruiting
Nadia Chaudhry, MD
CONTACT
Sophia Zackrisson, MD, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 2 days
Signal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.
Time frame: Immediately after photoacoustic imaging acquisition
The percentage of oxygenation within a region of interest (ROI)
Contact information is provided by the study sponsor or research team.
Nadia Chaudhry, MD
CONTACT
Sophia Zackrisson, MD, PhD
CONTACT
Region Skane
Other
Breast Cancer Diagnosis Using Optical Techniques
Acronym: CLEO-B
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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