Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies

Fresh breast core biopsies suspicious for breast cancer that are usually taken during clinical breast assessments will be imaged via confocal microscopy.

The device so called HistologTM Scanner is based on confocal fluorescence and displays microscopic histology images superficial layers of fresh tissue.

After the imaging procedure the fresh breast tissue specimen will be followed according to the gold standard workflow (H&E-stained images).

Subsequently, two pathologists will analyze the HistologTM Scanner obtained-images and H&E-stained images for potential breast cancer structures.

A comparison of both analyses for cancer visualization will be performed to evaluate the feasibility of using confocal microscopy for breast cancer detection.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

During clinical breast assessments physicians may detect diagnostic findings suspicious for breast cancer. In such situations a biopsy has to be taken to confirm the diagnosis histologically. Once informed consent will be obtained, the physician will collect a biopsy sample using the standard procedure with US- or MG-guided Biospy. Immediately prior to gold standard pathology workflow (formalin fixation), HistologTM Scanner will be used to image the fresh biopsy specimens. The HistologTM Scanner (v1.0, SamanTree Medical SA, Lausanne, Switzerland, CE marking) is based on confocal fluorescence and displays microscopic histology images of superficial layers of fresh tissue after nuclear staining with Acridine Orange (30 seconds) and rinsing in saline solution.

Finally, the specimen will be processed following the gold standard workflow (H&E-stained images).

Two independent pathologists will assess the HistologTM Scanner- and H&E-stained images subsequently according to the B-classification (categories B1-B5; "0" was defined as "no diagnosis possible") and determine the correspondence of the results.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Brust-Zentrum AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult female patients presenting lesions suspicious for breast carcinoma in ultrasound or mammography that are eligible for biopsy sampling and meet the research project's inclusion/exclusion criteria.

Description

Inclusion Criteria:

• Adult female patient ≥18 years old.
• Patient presenting with suspected breast carcinoma.
• Patient eligible for biopsy sampling.
• Patient must sign a written informed consent prior to research project entry.

Exclusion Criteria:

• Patient previously treated for breast carcinoma.
• Patient has undergone previous neo-adjuvant treatment.
• Patient is not willing to participate in the research project.
• Patient is not capable of consenting.
• Patient is younger than 18 years old
• Patient is male

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correspondence of pathologic assessment in specimen suspicious for breast cancer	Evaluate the correspondence of breast cancer diagnosis based on confocal HistologTM Scanner images in comparison with gold standard pathology assessment.	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the HistologTM Scanner confocal device	Assess the usability of the HistologTM Scanner confocal device in the context of breast surgery by gathering feedback and expert opinion from the medical staff involved in the research study.	up to 24 weeks
Acceptance of the HistologTM Scanner confocal device	Assess the acceptance of the HistologTM Scanner confocal device in the context of breast surgery by gathering feedback and expert opinion from the medical staff involved in the research study.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Brust-Zentrum AG
• Investigators: Principal Investigator: Christoph Tausch, MD, Brust-Zentrum AG Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2017
• Primary Completion (ACTUAL): November 15, 2017
• Study Completion (ACTUAL): December 11, 2017

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2017-00836

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No