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

NCT03530722 | Completed

• 1 other identifier: 2017-00836
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Usability of the HistologTM Scanner confocal device

  up to 24 weeks

• Acceptance of the HistologTM Scanner confocal device

  up to 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brust-Zentrum AG: lead

Study Sites (1)

Brust-Zentrum AG

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christoph Tausch, MD

  Brust-Zentrum AG Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 21, 2018
• Study Start: July 4, 2017
• Primary Completion: November 15, 2017
• Study Completion: December 11, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-04

Locations

CH (1)