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

NCT04976556 | Completed

• 1 other identifier: Hibiscuss
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Confocal Microscopy; Fresh Tissue Imaging; Intraoperative Assessment; Breast Conserving Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy for breast cancer diagnosis

  Through study completion, an average of 1 year

Interventions

Histolog Scanner DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient are selected by breast surgeons during their standard-of-care preoperative consultations

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SamanTree Medical SA: lead
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator

Study Sites (1)

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (1)

• 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.

  PMID: 37178160 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angelica Conversano, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

• Marie-Christine Mathieu, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 26, 2021
• Study Start: June 26, 2019
• Primary Completion: January 15, 2021
• Study Completion: December 31, 2021
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

FR (1)