Breast CancerHibiscussNCT04976556
Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope
An observational study of Breast Cancer, run by SamanTree Medical SA at 1 site in France.
Trial summary
Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Histolog Scanner
- Type of treatment
- Medical device
- How many people
- 181 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 31 Dec 2021
- 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: Patient are selected by breast surgeons during their standard-of-care preoperative consultations
Who may be able to join
- Adult female patient ≥18 years old
- Women with diagnosed, operable invasive or in situ ductal carcinoma, invasive lobular carcinoma who are deemed breast surgery candidates (i.e. lumpectomy or mastectomy).
- Patient able to read, understand and give informed consent
Who cannot join
- Patient not informed
- Patient previously treated for breast carcinoma
- Patient has undergone presurgical neo-adjuvant treatment
- Patient is pregnant/lactating
- Patient is male
- Participation in any other clinical study that would affect data acquisition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Carcinoma Detection in Ex-vivo Fresh Breast Surgical Specimens Using the Histolog Scanner, Slide-free Confocal Microscopy Scanner
Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device.
Read the detailed description
Breast cancer is the commonest cancer in female worldwide and breast-conserving surgery (BCS) became the most frequently performed surgical treatment for women with early-stage breast cancer. The ability to identify subclinical and deep-seated tumor during BCS is still difficult, and the surgeon must rely on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. Although there is no consensus on negative surgical margins, at least 20 % of patients undergo more than one procedure to achieve acceptable margins as part of breast-conserving strategy. The development of reliable intraoperative assessment tools which can provide a timely indication of whether re-excision in tumor bed after BCS is indicated at the time of primary surgery would be an asset. The Histolog Scanner is a recent confocal microscope designed for fresh tissue ex-vivo medical imaging with high resolution and speed to guide intraoperative assessment and offer support in clinical decision making. Allowing the quickest and most effective intraoperative assessment of breast surgical specimen regardless of center clinical workflow and intraoperative availability of pathologist, is the aim of this international study. The main objective is to demonstrate that both pathologists and surgeons are able to detect breast cancer tissues in Histolog Scanner images of breast surgical specimens.
Fresh Breast surgical specimens with breast cancer (invasive or in-situ) will be imaged with the Histolog Scanner prior Standard-of-Care final assessment in pathology. Content of the images will be reviewed by a board of expert pathologists using the gold standard (H\&E-stained images) as reference. Blind assessment of the breast cancer content of these Histolog Scanner images will be realized by breast surgeons and pathologist.
- Conditions
- Breast Cancer
- Being tested
- Histolog Scanner
- Keywords
- Breast cancer, Confocal Microscopy, Fresh Tissue Imaging, Intraoperative Assessment, Breast Conserving Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histolog ScannerDevice
imaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, Sensitivity, Specificity, Positive predictive value, Negative predictive value for breast cancer detection
Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Accuracy for breast cancer diagnosis
Quatification of the performance achieved by pathologists to differentiate breast cancer subtype (IDC, DCIS or ILC) in Histolog scanner images.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start26 Jun 2019
- Primary completion15 Jan 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- SamanTree Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- Angelica Conversano, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisMarie-Christine Mathieu, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976556
- Sponsor's protocol ID
- Hibiscuss
- Acronym
- Hibiscuss
- Status last verified
- Jun 2023
- First submitted
- 5 Jul 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conversano A, Abbaci M, van Diest P, Roulot A, Falco G, Ferchiou M, Coiro S, Richir M, Genolet PM, Clement C, Casiraghi O, Lahkdar AB, Labaied N, Ragazzi M, Mathieu MC. Breast carcinoma detection in ex vivo fresh human breast surgical specimens using a fast slide-free confocal microscopy scanner: HIBISCUSS project. BJS Open. 2023 May 5;7(3):zrad046. doi: 10.1093/bjsopen/zrad046.
PubMed 37178160
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Carcinoma Detection in Ex-vivo Fresh Breast Surgical Specimens Using the Histolog Scanner, Slide-free Confocal Microscopy Scanner
- ClinicalTrials.gov ID
- NCT04976556
- Acronym / sponsor ID
- Hibiscuss / Hibiscuss
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Confocal Microscopy, Fresh Tissue Imaging, Intraoperative Assessment, Breast Conserving Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- SamanTree Medical SAIndustry (pharma, biotech, devices)
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jul 2021 (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.
Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device.
Detailed description
Breast cancer is the commonest cancer in female worldwide and breast-conserving surgery (BCS) became the most frequently performed surgical treatment for women with early-stage breast cancer. The ability to identify subclinical and deep-seated tumor during BCS is still difficult, and the surgeon must rely on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. Although there is no consensus on negative surgical margins, at least 20 % of patients undergo more than one procedure to achieve acceptable margins as part of breast-conserving strategy. The development of reliable intraoperative assessment tools which can provide a timely indication of whether re-excision in tumor bed after BCS is indicated at the time of primary surgery would be an asset. The Histolog Scanner is a recent confocal microscope designed for fresh tissue ex-vivo medical imaging with high resolution and speed to guide intraoperative assessment and offer support in clinical decision making. Allowing the quickest and most effective intraoperative assessment of breast surgical specimen regardless of center clinical workflow and intraoperative availability of pathologist, is the aim of this international study. The main objective is to demonstrate that both pathologists and surgeons are able to detect breast cancer tissues in Histolog Scanner images of breast surgical specimens.
Fresh Breast surgical specimens with breast cancer (invasive or in-situ) will be imaged with the Histolog Scanner prior Standard-of-Care final assessment in pathology. Content of the images will be reviewed by a board of expert pathologists using the gold standard (H\&E-stained images) as reference. Blind assessment of the breast cancer content of these Histolog Scanner images will be realized by breast surgeons and pathologist.
Study design
- Observational model
- Other
- 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
- Patient are selected by breast surgeons during their standard-of-care preoperative consultations
Key inclusion criteria (3 listed)
- Adult female patient ≥18 years old
- Women with diagnosed, operable invasive or in situ ductal carcinoma, invasive lobular carcinoma who are deemed breast surgery candidates (i.e. lumpectomy or mastectomy).
- Patient able to read, understand and give informed consent
Key exclusion criteria (6 listed)
- Patient not informed
- Patient previously treated for breast carcinoma
- Patient has undergone presurgical neo-adjuvant treatment
- Patient is pregnant/lactating
- Patient is male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histolog Scannerimaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device | Device | – |
Primary outcome
Accuracy, Sensitivity, Specificity, Positive predictive value, Negative predictive value for breast cancer detection
Time frame: Through study completion, an average of 1 year
Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images
1 secondary outcome
Accuracy for breast cancer diagnosis
Time frame: Through study completion, an average of 1 year
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 15 Jun 2023.
- Derived from this study: PubMed 37178160Conversano A, Abbaci M, van Diest P, Roulot A, Falco G, Ferchiou M, Coiro S, Richir M, Genolet PM, Clement C, Casiraghi O, Lahkdar AB, Labaied N, Ragazzi M, Mathieu MC. Breast carcinoma detection in ex vivo fresh human breast surgical specimens using a fast slide-free confocal microscopy scanner: HIBISCUSS project. BJS Open. 2023 May 5;7(3):zrad046. doi: 10.1093/bjsopen/zrad046.
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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.
Angelica Conversano, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Marie-Christine Mathieu, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
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 SamanTree Medical SA at 1 site in France.
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 3 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 15 Jun 2023. 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 France. 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?
Accuracy, Sensitivity, Specificity, Positive predictive value, Negative predictive value for breast cancer detection (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04976556, which also lists 1 linked publication.
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 15 Jun 2023.