Clinical trial NCT03530722: Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies
Official title: Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Brust-Zentrum AG
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Correspondence of pathologic assessment in specimen suspicious for breast cancer
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Usability of the HistologTM Scanner confocal device
timeFrame: up to 24 weeks
measure: Acceptance of the HistologTM Scanner confocal device
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Brust-Zentrum AG
Study officials:
affiliation: Brust-Zentrum AG Zürich
name: Christoph Tausch, MD
role: PRINCIPAL_INVESTIGATOR
References: