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

Sponsor

SamanTree Medical SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05118568

Collaborator

St. Vincenz Krankenhaus GmbH, Paderborn (Other)

Enrollment

Location

19.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Histolog Scanner

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.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Imaging of Lumpectomy Surface With Large Field-of-View Confocal Laser Scanning Microscope 'Histolog Scanner' for Breast Margin Assessment in Comparison With Intraoperative Imaging and Postoperative Histopathological Assessment

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Feb 15, 2021

Anticipated Study Completion Date :

May 31, 2022

Outcome Measures

Primary Outcome Measures

Accuracy, Sensitivity, Specificity for breast cancer detection [Through study completion, an average of 6 months]
Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images of lumpectomy margins

Secondary Outcome Measures

Theoretical impact on re-operation rates [Through study completion, an average of 6 months]
Extrapolation of the re-operation rate reduction based on positive-margin detection achieved with the Histolog Scanner, in comparison with the local intraoperative margin assessment techniques.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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