Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2020-12-01
2027-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* understands written and oral Swedish
Exclusion Criteria
* has received neoadjuvant chemotherapy
* skin burns in on the chest
18 Years
FEMALE
Yes
Sponsors
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Lund University
OTHER
Unilabs
UNKNOWN
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Sophia Zackrisson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skane, Lund University
Locations
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Skane University Hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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photoacoustic center at Lund University
Other Identifiers
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Dnr 2019-04840
Identifier Type: -
Identifier Source: org_study_id
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