JOURNAL ONKOLOGIE – STUDIE

The ClearCoast™ Magnetic Resonance Outcome PMS Study

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05458739

Studienbeginn:
Juni 2021

Letztes Update:
08.02.2023

Wirkstoff:
-

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Clear Cut Medical Ltd.

Collaborator:
-

Kontakt

Anna Levin
Kontakt:
Phone: +972-8-6326004
E-Mail: alevin@clrcut.com» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Gynäkologisches Krebszentrum Agaplesion Markus Krankenhaus Frankfurt
Wilhelm-Epstein-Straße 4
60431 Frankfurt am Main
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Marc Thill, Prof.
Phone: +49 (069) 95 33 - 22 28
E-Mail: marc.thill@fdk.info» Ansprechpartner anzeigen

Western General Hospital , Breast Unit
Edinburgh
United KingdomNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
J Michael Dixon, Prof.
Phone: 01315372907
E-Mail: jmd@ed.ac.uk» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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).

Studien-Arme

Treatment Group
The removed specimen (as part of BCS) is scanned with 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.

Geprüfte Regime

ClearCoast MR System:
The removed specimen is scanned using the ClearCoast MR System.

Quelle: ClinicalTrials.gov

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