Benign Breast TumorsCLEO-BNCT06857669
Clinical Explorative Optical Breast Investigations
A study testing Diffuse reflectance spectroscopy and Photoacoustic imaging, in people with Benign Breast Tumors and Malignant Breast Tumours, run by Region Skane at 1 site in Sweden.
Trial summary
This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Breast Tumors, Malignant Breast Tumours, Healthy
- What is being tested?
- Diffuse reflectance spectroscopy and Photoacoustic imaging,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2020to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- solitary malignant or benign biopsy verified tumour > 1 cm
- understands written and oral Swedish
Who cannot join
- previous breast surgery
- has received neoadjuvant chemotherapy
- skin burns in on the chest
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nadia Chaudhry, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital
Malmö, 20502
Sophia Zackrisson, MD, PhD, +46 40 33 87 97, sophia.zackrisson@med.lu.se
Nadia Chaudhry, MD, nadia.chaudhry@med.lu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Breast Tumors, Malignant Breast Tumours, Healthy
- Being tested
- Diffuse reflectance spectroscopy and Photoacoustic imaging,
- Keywords
- breast, optical imaging, photoacoustic, spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse reflectance spectroscopy and Photoacoustic imaging,Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging) | Experimental | 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). Receives: Diagnostic Test: Diffuse reflectance spectroscopy and Photoacoustic imaging, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 2 days
To assess oxygenation levels across three breast tissue types using PAI
The percentage of oxygenation within a region of interest (ROI)
Measured: Immediately after photoacoustic imaging acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Breast TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Unilabs
- Responsible party
- Sponsor
- Investigators
- Sophia Zackrisson, MD, PhD, Principal investigator, Region Skane, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857669
- Sponsor's protocol ID
- Dnr 2019-04840
- Acronym
- CLEO-B
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 37835819
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Diagnosis Using Optical Techniques
- ClinicalTrials.gov ID
- NCT06857669
- Acronym / sponsor ID
- CLEO-B / Dnr 2019-04840
- Conditions
- Benign Breast Tumors, Malignant Breast Tumours, Healthy
- Keywords
- breast, optical imaging, photoacoustic, spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Unilabs
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging) | Experimental | Diagnostic Test: Diffuse reflectance spectroscopy and 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- solitary malignant or benign biopsy verified tumour > 1 cm
- understands written and oral Swedish
Key exclusion criteria (3 listed)
- previous breast surgery
- has received neoadjuvant chemotherapy
- skin burns in on the chest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging) |
Primary outcome
Number of study subjects with correctly classified breast tissue type with PAI/DRS
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.
2 secondary outcomes
Optical signal in relation to photoacoustic imaging depth
Time frame: 2 days
To assess oxygenation levels across three breast tissue types using PAI
Time frame: Immediately after photoacoustic imaging acquisition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Results publication: PubMed 37835819Chaudhry 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.
- photoacoustic center at Lund UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia Chaudhry, MD contact
Sophia Zackrisson, MD, PhD principal investigator
Region Skane, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffuse reflectance spectroscopy and Photoacoustic imaging, in people with Benign Breast Tumors and Malignant Breast Tumours, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Zackrisson, MD, PhD (+46 40 33 87 97, sophia.zackrisson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of study subjects with correctly classified breast tissue type with PAI/DRS (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.