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
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|
|Study Type :||Observational|
|Estimated Enrollment :||93 participants|
|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|
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 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.
- 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 - 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).
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
|Contact: Anna Levinfirstname.lastname@example.org|
|Agaplesion Markus Krankenhaus||Recruiting|
|Contact: Marc Thill, Prof. +49 (069) 95 33 - 22 28 email@example.com|
|Western General Hospital , Breast Unit||Not yet recruiting|
|Edinburgh, Scotland, United Kingdom|
|Contact: J Michael Dixon, Prof. 01315372907 firstname.lastname@example.org|