Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

imaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device

Histolog Scanner

Angelica Conversano, MD

Marie-Christine Mathieu, MD

Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device.

Breast cancer is the commonest cancer in female worldwide and breast-conserving surgery (BCS) became the most frequently performed surgical treatment for women with early-stage breast cancer. The ability to identify subclinical and deep-seated tumor during BCS is still difficult, and the surgeon must rely on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. Although there is no consensus on negative surgical margins, at least 20 % of patients undergo more than one procedure to achieve acceptable margins as part of breast-conserving strategy. The development of reliable intraoperative assessment tools which can provide a timely indication of whether re-excision in tumor bed after BCS is indicated at the time of primary surgery would be an asset. The Histolog Scanner is a recent confocal microscope designed for fresh tissue ex-vivo medical imaging with high resolution and speed to guide intraoperative assessment and offer support in clinical decision making. Allowing the quickest and most effective intraoperative assessment of breast surgical specimen regardless of center clinical workflow and intraoperative availability of pathologist, is the aim of this international study. The main objective is to demonstrate that both pathologists and surgeons are able to detect breast cancer tissues in Histolog Scanner images of breast surgical specimens.

Fresh Breast surgical specimens with breast cancer (invasive or in-situ) will be imaged with the Histolog Scanner prior Standard-of-Care final assessment in pathology. Content of the images will be reviewed by a board of expert pathologists using the gold standard (H\&E-stained images) as reference. Blind assessment of the breast cancer content of these Histolog Scanner images will be realized by breast surgeons and pathologist.

Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope

Breast Carcinoma Detection in Ex-vivo Fresh Breast Surgical Specimens Using the Histolog Scanner, Slide-free Confocal Microscopy Scanner

Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images

Quatification of the performance achieved by pathologists to differentiate breast cancer subtype (IDC, DCIS or ILC) in Histolog scanner images.

Gustave Roussy, Cancer Campus, Grand Paris

SamanTree Medical SA

All recruited patient will have their margins assessed with the confocal microscope with comparison of accuracy against gold standard histology.

Daniel R Leff, MBBS FRCS (Gen Surg) MS PhD

This is a clinical device trial to assess the accuracy of margin assessment for a confocal scanning device (Histolog Scanner) at assessing the margins of breast tissue following wide local excision surgery.

Currently a 15-20% of breast cancer patients have cancer cells seen at the edge of the tissue removed following. These patient will need to undergo a second operation to ensure all the cancer cells are removed, which has psychological, cosmetic and cost implications. Several technologies have been designed to allow the edges of tissue to be tested during surgery, with the most accurate being those that involve assessing the tissue edge at a cellular level. However, these techniques are time consuming which makes their use in routine work impractical.

The Histolog system uses pinhole (confocal) microscopy to capture cellular level images of the edge of tissue intra-operatively. The first generation of the device has been shown to be accurate for assessing breast tissue biopsies and skin cancer. The second generation of the device has an 8cm plate for scanning tissue and is CE marked for the assessment of tissue margins. This project is to show that the device is accurate for the assessment of margins, with further assessment in relation to the time for images to be captured and ease of interpretation to assess overall feasibility. The study would recruit at a single high volume breast cancer centre. The study will recruit patients with a diagnosis of breast cancer who are due to undergo breast conservation surgery (lumpectomy) with inclusion criteria of female patients over the age of 18 who are able to give informed consent. The study would involve the edges of removed tissue being imaged following surgery. These images would be reported by a consultant histopathologist and compared to the routine gold standard histology. There is no change to patient care and the device will not be used to change the surgery performed. There are no questionnaires or additional demands placed on the participants.

Histolog Comparison to Standard Histology

Do the Results of Intra-operative Margin Assessment Correlate With the Output of Conventional Histology for Patient Undergoing Breast Conservation Surgery?

To compare the sensitivity and specificity of involved margins being assessed intra-operatively using Histolog® Scanner system against conventional histology reporting for patient undergoing breast conservation surgery for breast cancer.

Imperial College London

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.

Michael P Lux, Prof. Dr MBA

This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.

Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment

Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)

Differences in the rate of reoperation due to cancer positive margins

To observe real life clinical performance of the HLS and accessories when used intraoperatively

To survey usability of the HLS and accessories when used intraoperatively

To evaluate the economic impact for the hospital/payer of the reoperation rate

Incidence of adverse device effects during surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope	NCT04976556	Breast Cancer	Histolog Scanne...	18 Years -	SamanTree Medical SA
Histolog Comparison to Standard Histology	NCT04857229	Margins of Exci... Breast Cancer	Histolog Scanne...	18 Years -	Imperial College London
Histolog Comparison to Standard Histology	NCT04857229	Margins of Exci... Breast Cancer	Histolog Scanne...	18 Years -	Imperial College London
Histolog Comparison to Standard Histology	NCT04857229	Margins of Exci... Breast Cancer	Histolog Scanne...	18 Years -	Imperial College London
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment	NCT05946759	Breast Cancer -... Breast-Conservi...	Histolog Scanne...	18 Years -	SamanTree Medical SA

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