The ClearCoast™ Magnetic Resonance Outcome PMS Study

The ClearCoast™ Magnetic Resonance Outcome Post Marketing Surveillance Study

Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. All study patients and the patients in the historical control group will be required to meet the study eligibility criteria.

BCS will be performed with the routine standard of care (SOC), including intra-operative methods used to improve margin assessment. In addition to SOC process, the main specimen from patients found eligible will be scanned in the ClearCoast™ system. The surgeon will utilize the information from the ClearCoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. The decision-making process including MR images interpretation and the surgical decisions will be evaluated and documented. Following procedure, routine histopathology examination will be performed accompanied by the ClearCoast optical and parametric maps.

This study is a controlled design, in which subjects previously having undergone BCS by the same surgeons, will serve as the historical control group, comparing the following endpoints:

• Complete surgical re-excision rate
• Total excised breast tissue volume

The study Control group is composed of historical data from patients previously undergone BCS, under the same site SOC surgical practice, practicing surgeons, and study eligible criteria. This allows reducing inter-group variability and bias.

A device operator trained by ClearCut Medical will operate the device throughout the study.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: ClearCoast MR System

• Study Type: Observational
• Enrollment (Anticipated): 93

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany
    • Recruiting
    • Agaplesion Markus Krankenhaus
• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom
      • Not yet recruiting
      • Western General Hospital , Breast Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of women 18 years of age and/or over, who are diagnosed with invasive and/or in situ carcinoma of the breast.

Description

Inclusion Criteria:

1. Women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
2. Age ≥18

3. Patient is willing and capable to provide written Informed Consent Form (ICF)

   Exclusion Criteria:

4. Prior surgical procedure in the same breast within 12 months prior to the surgery date
5. Recurrent breast cancer surgery
6. Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
7. Previous radiation therapy in the operated breast
8. Pregnancy
9. Lactation
10. Patient has subglandular breast implants in the operated breast
11. moribund patient and/or patient with comorbidities, per principal investigator discretion

12. Participating in any other investigational study for either drug or device which might influence collection of valid data under this study.

    Intraoperative:

13. Specimen undergoing pathological specimen assessment (e.g. by frozen section, imprint cytology or gross assessment by sectioning), resulting in deformation of specimen shape/tissue properties (e.g. Formalin conservation)
14. Specimen dimension is larger than the Tissue container volume (200cc)
15. Inability to define aspect color/orientation and/or margin border

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; The removed specimen (as part of BCS) is scanned with the ClearCoast MR System.	Device: ClearCoast MR System; The removed specimen is scanned using the ClearCoast MR System.
Historical Group; Historical data of patients undergone BCS, under the same eligibility criteria and performed by the same study surgeons, thus minimizing inter-groups and inter-surgeon variability and bias, will serve as a control group for the comparison of the complete resection rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ClearCoast™ Success rate	the success of the ClearCoast™ system indicating abnormal margins of breast tissue specimen intra-operatively. This endpoint compares the proportion of patients that undergo a re-excision surgery following the primary lumpectomy procedure between the two groups.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome - Re-excision rate	Comparing the percentage of positive margins (%) of the main specimen (as detected by post-operative microscopically as having cancer within 1mm or less of the inked surface) and document which of those positive margins have been addressed by intra-operative re-excision or the absence of further tissue to be re-excised (e.g., undermining the skin or reaching the pectoralis fascia).	1 year

Collaborators and Investigators

• Sponsor: Clear Cut Medical Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2021
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (ACTUAL): July 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 735CLD Rev.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No