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

Nervous System Diseases

Skin Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Yi-Hua YH Liao, PhD

Yao-Chen YC Tseng, Master

Yi-Hua Liao

The goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are:

• to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology.

Participants will provide a small piece of their surgical specimens from tumor removal surgery .

If there is a comparison group: Researchers will compare normal specimens to see if we can observe the difference.

Microscopy Imaging of Whole-mount Stained Human Tissues

Microscopy Imaging of Whole-mount Stained Human Tissues: Development of an Imaging Platform for Intraoperative Tumor Margin Delineation

Do comparison with images acquired by our microscopy (with the whole-mount staining method) and bright field microscopy (with standard FFPE method) and do assessment to interpret tumor characteristics

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
Microscopy Imaging of Whole-mount Stained Human Tissues	NCT05689112	Tumor, Brain Tumor, Breast Tumor Skin		20 Years -	National Taiwan University Hospital
Microscopy Imaging of Whole-mount Stained Human Tissues	NCT05689112	Tumor, Brain Tumor, Breast Tumor Skin		20 Years -	National Taiwan University Hospital
Microscopy Imaging of Whole-mount Stained Human Tissues	NCT05689112	Tumor, Brain Tumor, Breast Tumor Skin		20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for intraoperative assessment