An interventional study of Histolog Scanner in Breast Cancer Invasive, Breast Cancer Surgery and Lumpectomy, sponsored by University of Fribourg. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by University of Fribourg · Not applicable, Interventional, and Treatment
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.
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
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
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Histolog Scanner
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.
Reoperation Rate
Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
Time frame: From enrollment to the end of treatment (surgery) at 1 month
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)
Time frame: 1 year
Usability
\- Usability rates of HLS and accessories: analysis time
Time frame: 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
Time frame: 1 year
Incidence of adverse device effects
Incidence of adverse device effects during the surgery.
Time frame: 14 month
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