The ClearCoast™ Magnetic Resonance Outcome PMS Study

NCT05458739 | Completed

• 1 other identifier: 735CLD Rev.04
• Study Type: observational
• Target: 93
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Outcome - Re-excision rate

  1 year

Study Arms (2)

Treatment Group

The removed specimen (as part of BCS) is scanned with the ClearCoast MR System.

Device: 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.

Interventions

ClearCoast MR System DEVICE

The removed specimen is scanned using the ClearCoast MR System.

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
• Age ≥18
• Patient is willing and capable to provide written Informed Consent Form (ICF)

You may not qualify if:

• Prior surgical procedure in the same breast within 12 months prior to the surgery date
• Recurrent breast cancer surgery
• Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
• Previous radiation therapy in the operated breast
• Pregnancy
• Lactation
• Patient has subglandular breast implants in the operated breast
• moribund patient and/or patient with comorbidities, per principal investigator discretion
• Participating in any other investigational study for either drug or device which might influence collection of valid data under this study.
• Intraoperative:
• 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)
• Specimen dimension is larger than the Tissue container volume (200cc)
• Inability to define aspect color/orientation and/or margin border

Sponsors & Collaborators

• Clear Cut Medical Ltd.: lead

Study Sites (2)

Agaplesion Markus Krankenhaus

Frankfurt, Germany

Location

Western General Hospital , Breast Unit

Edinburgh, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 14, 2022
• Study Start: June 24, 2021
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (1)