Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06857669

Breast Cancer Diagnosis Using Optical Techniques

Led by Region Skane · Updated on 2026-04-29

90

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

R

Region Skane

Lead Sponsor

L

Lund University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Breast cancer is a common cancer among women globally, and current diagnostic methods have limitations such as exposure to radiation and the need for invasive biopsies. Researchers are evaluating two optical imaging techniques, diffuse reflectance spectroscopy (DRS) and photoacoustic imaging (PAI), to differentiate healthy, benign, and malignant breast tissues by identifying their unique optical profiles. This study aims to assess these methods as non-invasive, contrast-free alternatives to traditional imaging for breast cancer diagnosis or monitoring. The study has three parts: first, 30 breast tissue samples will be examined outside the body using DRS; second, 30 samples will be examined ex-vivo using both DRS and PAI; third, 30 participants will undergo in-vivo examination using PAI. The DRS device uses white light to generate optical signals, while PAI combines ultrasound with optical imaging to create functional images that may assess tissue oxygenation differences. Participants will be evaluated through these imaging techniques to classify tissue types accurately. Outcomes include the number of subjects with correctly classified breast tissue using PAI and DRS, optical signal depth, and oxygenation levels in different tissue types. The study uses non-invasive imaging without ionizing radiation or contrast agents, with evaluations completed within days after imaging. Total participation time varies by study part.

CONDITIONS

Brief Title

Clinical Explorative Optical Breast Investigations

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Solitary malignant or benign biopsy verified tumor larger than 1 cm
  • Understands written and oral Swedish
Not Eligible

You will not qualify if you...

  • Previous breast surgery
  • Has received neoadjuvant chemotherapy
  • Skin burns on the chest

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single assessment day

Participants undergo non-invasive optical diagnostic tests including diffuse reflectance spectroscopy (DRS) and photoacoustic imaging (PAI) to analyze breast tissue types.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 30 days

Participants are observed to evaluate the accuracy of optical diagnostic techniques for breast tissue classification over time.

Follow-up assessments may occur within 30 days

Trial Site Locations

Total: 1 location

1

Skane University Hospital

Malmö, Sweden, 20502

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Research Team

S

Sophia Zackrisson, MD, PhD

N

Nadia Chaudhry, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Breast Cancer Diagnosis Using Extended-Wavelength-Diffuse Reflectance Spectroscopy (EW-DRS)-Proof of Concept in Ex Vivo Breast Specimens Using Machine Learning.

Nadia Chaudhry, John Albinsson, Magnus Cinthio...

https://pubmed.ncbi.nlm.nih.gov/37835819