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

NCT ID: NCT04976556

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2021-12-31

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Histolog Scanner

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: collaborator

SamanTree Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angelica Conversano, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Marie-Christine Mathieu, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37178160 (View on PubMed)

Other Identifiers

Hibiscuss

Identifier Type: -

Identifier Source: org_study_id