Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope

Breast Cancer Clinical Trial

— Hibiscuss  

Official title:

Breast Carcinoma Detection in Ex-vivo Fresh Breast Surgical Specimens Using the Histolog Scanner, Slide-free Confocal Microscopy Scanner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976556
• Other study ID #: Hibiscuss
• Status: Completed
• Start date: June 26, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2023
• Source: SamanTree Medical SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 31, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Histolog Scanner
imaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
SamanTree Medical SA	Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year