An observational study in Breast Cancer, sponsored by Brust-Zentrum AG. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-21.
Sponsored by Brust-Zentrum AG · Observational
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.
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.
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.
Exclusion Criteria:
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.
Time frame: up to 24 weeks
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.
Time frame: 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.
Time frame: up to 24 weeks
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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