Confocal Histolog Scanner for checking margins during lumpectomy
Confocal Histolog Scanner in Routine Breast-Conserving Surgery
This project will test whether using a confocal Histolog Scanner during lumpectomy helps surgeons find cancer at the edges of removed tissue and reduce the need for repeat operations in women having breast-conserving surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Fribourg Academic / other |
| Locations | 1 site (Villars-sûr-glâne, Canton of Fribourg) |
| Trial ID | NCT06958991 on ClinicalTrials.gov |
What this trial studies
This interventional clinical performance study uses a CE-marked Histolog® confocal laser scanning microscope to image excised breast tissue specimens intraoperatively and collect real‑world data on its use during breast‑conserving surgery. The device provides rapid, high‑resolution visualization of tissue microstructure to help surgeons identify positive margins and decide on immediate additional excision. Subjects are adult women undergoing lumpectomy for invasive cancer and/or DCIS and are managed according to routine surgical care with the scanner added into the intraoperative workflow. The primary focus is to observe reoperation rates when the Histolog Scanner is used for margin assessment in routine practice at the participating center.
Who should consider this trial
Good fit: Adult women (≥18 years) scheduled for breast‑conserving surgery for invasive carcinoma and/or DCIS who can read and sign the informed consent and will have their operation at the participating center.
Not a fit: Patients planned for mastectomy, those undergoing tumor‑adapted breast reduction, pregnant or lactating women, non‑French speakers at this site, or those enrolled in conflicting clinical studies are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the scanner could reduce the number of repeat surgeries by allowing surgeons to remove remaining cancer at the time of the initial operation, improving cosmetic and economic outcomes.
How similar studies have performed: Earlier single‑center and multicenter studies (SENOSI in Switzerland and POLARHIS and HELIXIR in Germany) reported promising results with confocal imaging for margin detection, but broader real‑world evaluation is still ongoing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Villars-sûr-glâne, Canton of Fribourg
- Hfr — Villars-sûr-glâne, Canton of Fribourg, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.