Breast Cancer InvasiveCHiBNCT06958991
Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)
A study testing Histolog Scanner in people with Breast Cancer Invasive and Breast Cancer Surgery, run by University of Fribourg at 1 site in Switzerland.
Trial summary
The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive, Breast Cancer Surgery, Lumpectomy
- What is being tested?
- Histolog Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2025to 30 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female Subject ≥18 years old.
- Subject scheduled for breast conserving surgery of invasive and/or in-situ ductal and lobular carcinoma.
- Subject is able to read, understand and sign the informed consent.
Who cannot join
- Subject with planned mastectomy
- Subject does not speak French- Subject with planned tumor-adapted breast reduction
- Subject is pregnant/ lactating. Subjects pregnant/lactating are excluded because such subjects are presenting additional risks during the surgery and they are also rare.
- Participation in any other clinical study that would affect data acquisition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
HFR
Villars-sûr-glâne, Canton of Fribourg, 1752
Benedetta Guani BG HFR Fribourg - Hôpital cantonal, 0041263062956, benedetta.guani@h-fr.ch
About this study
Official title: Confocal Histolog Scanner in Routine Breast-Conserving Surgery
The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.
Read the detailed description
Breast cancer is the most common cancer in women. Moreover, numerous women have the diagnosis of a ductal carcinoma in situ (DCIS) each year, which can develop to invasive breast cancer without therapy. Breast conserving surgery (BCS) is the most performed surgical treatment for women with early-stage breast cancer and/ or DCIS. There is an ongoing need for more immediate and accurate methods for the intraoperative assessment (IOA) of breast tissue margins to achieve tumor free margins. A method for rapidly and accurately identifying positive surgical margins intraoperatively would allow the surgeon to immediately excise additional tissue to achieve negative margins. Thereby sparing the Subject a reoperation with all following consequences i.e., reduced oncological safety, reduced cosmetic, and economic burden. The Histolog® Scanner (HLS), a confocal laser scanning microscope was developed with the CE Mark intended use of imaging excised human tissue specimens to visualize morphological microstructures. Such a feature allows real-time IOA offering cutting edge imaging support beyond the conventional imaging techniques in clinical decision making. Promising results have been previously obtained in the SENOSI study of Sion (Switzerland) and the POLARHIS and HELIXIR studies in Germany. Therefore, this study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when the HLS is used in the context of breast tissue margin assessment.
Primary Objective:
Evaluate the proportion of patients that had a surgical reoperation due to cancer-positive margins (Reoperation Rate).
Secondary Objectives:
Detection Rate
- To evaluate real life detection of breast cancerwhen the HLS and accessories are used intraoperatively by surgeons for the assessment of breast surgical specimens in comparison with the final pathology assessment (gold standard) Usability
- To survey usability of the HLS and accessories when used intraoperatively by surgeons for the assessment of breast surgical specimens Economic Impact
- To evaluate the economic impact for the hospitals/payers of the reoperation rate achieved by the use of the HLS and accessories for the assessment of breast surgical specimens Safety
- To monitor the safety of HLS and accessories when used intraoperatively by surgeons for the assessment of breast surgical specimens
Primary Endpoint:
Reoperation Rate
- Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
Secondary Endpoints:
Detection Rate
- Proportion of women for whom an unsafe margin was detected with HLS
- Agreement between margin cancerous status of the main surgical specimen and of recuts determined intraoperatively with the HLS and postoperative final pathology assessment using histological slides
- Rates of the intraoperative recuts depending on the different evaluation tools (HLS, ultrasound and specimen radiography)
- Weight and dimensions of surgical specimens
- HLS usage time on surgical specimens and recuts Usability
- Usability rates of HLS and accessories including image acquisition, processing, and analysing time
- Relevant tissue microstructures recognition by surgeons/ user
- HLS and accessories ease of use
- Rate of HLS' damage to tissue specimens
Economic Impact
- Change in hospital cost per patient with BCS with or without using the HLS and accessories. This will be evaluated by monitoring the costs of breast conserving surgeries and the costs related to the use of the HLS including device price, HLS consumables, time of use of the HLS, reoperation rates and their associated surgical resources.
Safety
- Incidence of adverse device effects during the surgery.
- Being tested
- Histolog Scanner
- Keywords
- breast cancer surgery, confocal microscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histolog ScannerDevice
The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer patient with Lumpectomy | Experimental | The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product. Receives: Device: Histolog Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation Rate
Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
Measured: From enrollment to the end of treatment (surgery) at 1 month
Secondary outcomes (4)
Detection Rate
- Agreement between margin cancerous status of the main surgical specimen and of recuts determined intraoperatively with the HLS and postoperative final pathology assessment using histological slides (sensibility and specificity)
Measured: 1 year
Usability
- Usability rates of HLS and accessories: analysis time
Measured: 1 year
Economic Impact
- Change in hospital cost per patient with BCS with or without using the HLS and accessories. This will be evaluated by comparing the usual average cost of breast conserving surgeries and the costs related to the use of the HLS during the surgery
Measured: 1 year
Incidence of adverse device effects
Incidence of adverse device effects during the surgery.
Measured: 14 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Jun 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958991
- Sponsor's protocol ID
- 2024-D0101
- Other IDs
- 20240829
- Acronym
- CHiB
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Histolog Scanner in Routine Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT06958991
- Acronym / sponsor ID
- CHiB / 2024-D0101
- Keywords
- breast cancer surgery, confocal microscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 May 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.
The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.
Detailed description
Breast cancer is the most common cancer in women. Moreover, numerous women have the diagnosis of a ductal carcinoma in situ (DCIS) each year, which can develop to invasive breast cancer without therapy. Breast conserving surgery (BCS) is the most performed surgical treatment for women with early-stage breast cancer and/ or DCIS. There is an ongoing need for more immediate and accurate methods for the intraoperative assessment (IOA) of breast tissue margins to achieve tumor free margins. A method for rapidly and accurately identifying positive surgical margins intraoperatively would allow the surgeon to immediately excise additional tissue to achieve negative margins. Thereby sparing the Subject a reoperation with all following consequences i.e., reduced oncological safety, reduced cosmetic, and economic burden. The Histolog® Scanner (HLS), a confocal laser scanning microscope was developed with the CE Mark intended use of imaging excised human tissue specimens to visualize morphological microstructures. Such a feature allows real-time IOA offering cutting edge imaging support beyond the conventional imaging techniques in clinical decision making. Promising results have been previously obtained in the SENOSI study of Sion (Switzerland) and the POLARHIS and HELIXIR studies in Germany. Therefore, this study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when the HLS is used in the context of breast tissue margin assessment.
Primary Objective:
Evaluate the proportion of patients that had a surgical reoperation due to cancer-positive margins (Reoperation Rate).
Secondary Objectives:
Detection Rate
- To evaluate real life detection of breast cancerwhen the HLS and accessories are used intraoperatively by surgeons for the assessment of breast surgical specimens in comparison with the final pathology assessment (gold standard) Usability
- To survey usability of the HLS and accessories when used intraoperatively by surgeons for the assessment of breast surgical specimens Economic Impact
- To evaluate the economic impact for the hospitals/payers of the reoperation rate achieved by the use of the HLS and accessories for the assessment of breast surgical specimens Safety
- To monitor the safety of HLS and accessories when used intraoperatively by surgeons for the assessment of breast surgical specimens
Primary Endpoint:
Reoperation Rate
- Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
Secondary Endpoints:
Detection Rate
- Proportion of women for whom an unsafe margin was detected with HLS
- Agreement between margin cancerous status of the main surgical specimen and of recuts determined intraoperatively with the HLS and postoperative final pathology assessment using histological slides
- Rates of the intraoperative recuts depending on the different evaluation tools (HLS, ultrasound and specimen radiography)
- Weight and dimensions of surgical specimens
- HLS usage time on surgical specimens and recuts Usability
- Usability rates of HLS and accessories including image acquisition, processing, and analysing time
- Relevant tissue microstructures recognition by surgeons/ user
- HLS and accessories ease of use
- Rate of HLS' damage to tissue specimens
Economic Impact
- Change in hospital cost per patient with BCS with or without using the HLS and accessories. This will be evaluated by monitoring the costs of breast conserving surgeries and the costs related to the use of the HLS including device price, HLS consumables, time of use of the HLS, reoperation rates and their associated surgical resources.
Safety
- Incidence of adverse device effects during the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer patient with Lumpectomy | Experimental | Device: Histolog ScannerThe clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult female Subject ≥18 years old.
- Subject scheduled for breast conserving surgery of invasive and/or in-situ ductal and lobular carcinoma.
- Subject is able to read, understand and sign the informed consent.
Key exclusion criteria (4 listed)
- Subject with planned mastectomy
- Subject does not speak French- Subject with planned tumor-adapted breast reduction
- Subject is pregnant/ lactating. Subjects pregnant/lactating are excluded because such subjects are presenting additional risks during the surgery and they are also rare.
- Participation in any other clinical study that would affect data acquisition.
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 |
|---|---|---|
| Histolog ScannerThe clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product. | Device | Breast Cancer patient with Lumpectomy |
Primary outcome
Reoperation Rate
Time frame: From enrollment to the end of treatment (surgery) at 1 month
Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
4 secondary outcomes
Detection Rate
Time frame: 1 year
Usability
Time frame: 1 year
Economic Impact
Time frame: 1 year
Incidence of adverse device effects
Time frame: 14 month
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 25 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histolog Scanner in people with Breast Cancer Invasive and Breast Cancer Surgery, run by University of Fribourg at 1 site in Switzerland.
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 3 inclusion and 4 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 25 Nov 2025. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation Rate (time frame: From enrollment to the end of treatment (surgery) at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.