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

NCT ID: NCT03530722

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-04
• Study Completion Date: 2017-12-11

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brust-Zentrum AG

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Tausch, MD

Role: PRINCIPAL_INVESTIGATOR

Brust-Zentrum AG Zürich

Locations

Brust-Zentrum AG

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2017-00836

Identifier Type: -

Identifier Source: org_study_id