Clinical Explorative Optical Breast Investigations (CLEO-B)
Breast Cancer Diagnosis Using Optical Techniques
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
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-
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Malmo, Sweden, 20502
- Recruiting
- Skåne University Hospital
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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
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of study subjects with correctly classified breast tissue type with PAI/DRS
Time Frame: 30 days
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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.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optical signal in relation to photoacoustic imaging depth
Time Frame: 2 days
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Signal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.
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2 days
|
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To assess oxygenation levels across three breast tissue types using PAI
Time Frame: Immediately after photoacoustic imaging acquisition
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The percentage of oxygenation within a region of interest (ROI)
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Immediately after photoacoustic imaging acquisition
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sophia Zackrisson, MD, PhD, Region Skåne, Lund University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2019-04840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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