Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques

NCT ID: NCT05118568

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-05-31

Brief Summary

Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.

Detailed Description

Breast cancer is the most common cancer in women. For early-stage breast cancers, breast-conserving surgery (BCS) is applied to excise the tumor while saving surrounding healthy tissue as much as possible to avoid radical excisions and achieve better aesthetic and psychological outcomes for the patient. This surgical approach requires postoperative tumor-free margin assessment of the surgical resection in order to carry on with next steps of the patient care treatment (e.g. radiotherapy). Unfortunately, at least 20% of patient undergo more than one procedure to achieve acceptable margin status due to difficulties to identify subclinical and deep-seated tumor during BCS. During the surgery, the surgeon mainly relies on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. While these determinants enable bulk tumor assessment, they do not offer the information to adequately identify tumor infiltrates on lumpectomy margin.

An efficient intraoperative assessment of the margin may solve these issues and confocal imaging has shown some promises by providing real-time imaging of fresh tissue with the resolution sufficient to visualize microscopic tissue features. The Histolog Scanner is a recent confocal microscope designed for clinical use on large surgical specimens.

The main objective of this study is to confirm that the use of the Histolog Scanner by surgeons allows to detect breast cancer on lumpectomy margins and compare the performance of the detection with local standard-of-care intraoperative imaging techniques (ultrasound and radiography) using the final assessment performed in pathology as reference.

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
• Patient Scheduled for breast conserving surgery of invasive and/ or in situ ductal carcinoma (DCIS).
• Patient able to read, understand and give informed consent

Exclusion Criteria

• Patient previously treated for ipsilateral breast cancer surgery
• Patient with previous radiotherapy of the breast
• Patient with multicentric breast cancer
• Patients with planed mastectomy, tumor-adapted breast reduction
• Patient with presurgical neo-adjuvant treatment
• Patient is pregnant/lactating
• Participation in any other clinical study that would affect data acquisition

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

Sponsors

St. Vincenz Krankenhaus GmbH, Paderborn

UNKNOWN

Sponsor Role: collaborator

SamanTree Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael P Lux, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

St. Vincenz-Krankenhaus GmbH

Locations

St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise

Paderborn, , Germany

Countries

Germany

Other Identifiers

Polarhis

Identifier Type: -

Identifier Source: org_study_id