Breast CancerNCT03530722
Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies
An observational study of Breast Cancer, run by Brust-Zentrum AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jul 2017to 11 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start4 Jul 2017
- Primary completion15 Nov 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brust-Zentrum AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Tausch, MD, Principal investigator, Brust-Zentrum AG Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530722
- Sponsor's protocol ID
- 2017-00836
- Other IDs
- 2017
- Status last verified
- Apr 2018
- First submitted
- 19 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies
- ClinicalTrials.gov ID
- NCT03530722
- Acronym / sponsor ID
- 2017-00836
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brust-Zentrum AGUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correspondence of pathologic assessment in specimen suspicious for breast cancer
Time frame: up to 24 weeks
Evaluate the correspondence of breast cancer diagnosis based on confocal HistologTM Scanner images in comparison with gold standard pathology assessment.
2 secondary outcomes
Usability of the HistologTM Scanner confocal device
Time frame: up to 24 weeks
Acceptance of the HistologTM Scanner confocal device
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Tausch, MD principal investigator
Brust-Zentrum AG Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Brust-Zentrum AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correspondence of pathologic assessment in specimen suspicious for breast cancer (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.