Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)

University of Fribourg

Status

Not yet enrolling

Conditions

Breast Cancer Surgery

Breast Cancer Invasive

Lumpectomy

Confocal Laser Endomicroscopy

Treatments

Device: Histolog Scanner

Study type

Interventional

Funder types

Other

Identifiers

NCT06958991

20240829 (Other Grant/Funding Number)

2024-D0101

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.