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The ClearCoast™ Magnetic Resonance Outcome PMS Study

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ClinicalTrials.gov Identifier: NCT05458739
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Clear Cut Medical Ltd.

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.


Condition or disease Intervention/treatment
Breast Cancer Device: ClearCoast MR System

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Study Type : Observational
Estimated Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ClearCoast™ Magnetic Resonance Outcome Post Marketing Surveillance Study
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. ClearCoast™ Success rate [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures :
  1. Secondary Outcome - Re-excision rate [ Time Frame: 1 year ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05458739


Contacts
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Contact: Anna Levin +972-8-6326004 alevin@clrcut.com

Locations
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Germany
Agaplesion Markus Krankenhaus Recruiting
Frankfurt, Germany
Contact: Marc Thill, Prof.    +49 (069) 95 33 - 22 28    marc.thill@fdk.info   
United Kingdom
Western General Hospital , Breast Unit Not yet recruiting
Edinburgh, Scotland, United Kingdom
Contact: J Michael Dixon, Prof.    01315372907    jmd@ed.ac.uk   
Sponsors and Collaborators
Clear Cut Medical Ltd.
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Responsible Party: Clear Cut Medical Ltd.
ClinicalTrials.gov Identifier: NCT05458739    
Other Study ID Numbers: 735CLD Rev.04
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No