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

NCT03530722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2018-05-21

No results posted yet for this study

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

Sponsors & Collaborators

  • Brust-Zentrum AG

    lead OTHER

Principal Investigators

  • Christoph Tausch, MD · Brust-Zentrum AG Zürich

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-04
Primary Completion
2017-11-15
Completion
2017-12-11

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530722 on ClinicalTrials.gov