Clinical Explorative Optical Breast Investigations (CLEO-B)

Breast Cancer Diagnosis Using Optical Techniques

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

Study Overview

• Status: Recruiting
• Conditions: Healthy; Malignant Breast Tumours; Benign Breast Tumors
• Intervention / Treatment: Diagnostic test: Diffuse reflectance spectroscopy and Photoacoustic imaging,

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Zackrisson, MD, PhD; Phone Number: +46 40 33 87 97; Email: sophia.zackrisson@med.lu.se
• Study Contact Backup: Name: Nadia Chaudhry, MD; Email: nadia.chaudhry@med.lu.se

Study Locations

• Sweden
  • Malmo, Sweden, 20502
    • Recruiting
    • Skåne University Hospital
    • Contact: Sophia Zackrisson, MD, PhD; Phone Number: +46 40 33 87 97; Email: sophia.zackrisson@med.lu.se
    • Contact: Nadia Chaudhry, MD; Email: nadia.chaudhry@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging); In part I, 30 breast specimens will be examined by DRS (ex-vivo). In part II, 30 breast specimens will be examined by both DRS and PAI (ex-vivo). In part III, 30 individuals will be examined by PAI (in-vivo).	Diagnostic test: Diffuse 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of study subjects with correctly classified breast tissue type with PAI/DRS	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical signal in relation to photoacoustic imaging depth	Signal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.	2 days
To assess oxygenation levels across three breast tissue types using PAI	The percentage of oxygenation within a region of interest (ROI)	Immediately after photoacoustic imaging acquisition

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Unilabs
• Investigators: Principal Investigator: Sophia Zackrisson, MD, PhD, Region Skane, Lund University

Publications and helpful links

General Publications

• 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.

Helpful Links

• photoacoustic center at Lund University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast; spectroscopy; optical imaging; photoacoustic
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Dnr 2019-04840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. A minimal data set could, however, be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with EU legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No