Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Study Overview
=================
Brief Summary
-----------------
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

Detailed Description
-----------------
ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.

Official Title
-----------------
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: ClearEdge device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are female (genotype) Patients aged above 18 years, inclusive Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure Patients treated with neoadjuvant endocrine therapy may be enrolled Exclusion Criteria: Patients currently receiving chemotherapy Patients having prior ipsilateral surgical treatment for breast cancer Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma) Patients who have breast implants Patients who are pregnant and/or lactating Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multi-center, pivotal prospective, randomized clinical trial of the effect of imaging the excision specimen during surgical treatment of breast cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SoC+ClearEdge device - Standard of Care + study device<br>Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery plus the use of the study device to assess for breast cancer cells at the the margins | Device: ClearEdge device<br>* ClearEdge tissue imaging device uses a new technology to detect tissue abnormalities at the surgical margins of a surgically excised breast tissue specimen. Adding the use of the imaging device has the potential to assist the surgeon in identifying DCIS or invasive cancer involved margins of the excised specimen.<br>|
| No Intervention: SoC - Standard of Care<br>Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with positive margins post-op | The percentage of patients with DCIS or invasive cancer involved margins as determined by pathology PM after evaluation with SoC or SoC+ClearEdge. | In the operating room compared to pathology assessment within 1 week post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FN and FP rates | The per-patient FN rate and FP rate for SoC compared to permanent section pathology | within weeks post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, lumpectomy, positive surgical margins