Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.

Detailed Description
-----------------
Optical coherence tomography (OCT) -- the optical analogue of high-frequency ultrasound -- is well suited for operative suite decision making because it offers real-time, high-resolution tissue imaging with a penetration depth up to 2 mm. The 2 mm depth of penetration is sufficient to accommodate the current national US (and international) guidelines which state that following resection there should be no tumor on ink for invasive cancer and not less than a 2 mm margin for DCIS in the absence of invasive disease. Recently, automated image analysis has demonstrated the potential to both improve diagnostic accuracy and reduce overall assessment time. OCT combined with deep learning algorithms has the potential to aid surgeons in identifying regions of interest on scanned samples, enabling them to make key decisions on margin status intraoperatively.

Official Title
-----------------
A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.

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

Intervention / Treatment
-----------------
* Device: Selene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18 years or older Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Male Metastatic cancer (Stage IV) Lobular carcinoma as primary diagnosis Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation) Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen Subjects with bilateral disease (diagnosed cancer in both breasts) Participating in any other investigational margin assessment study which can influence collection of valid data under this study Use of cryo-assisted localization Currently lactating Current pregnancy Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, randomized, double-arm trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Lumpectomy with usual intraoperative margin assessment | |
| Experimental: Device<br>Imaging of all margins with investigational device | Device: Selene<br>* SELENE imaging of all margins, with record of each margin assessment and an opportunity to excise tissue from the lumpectomy cavity post-imaging. The new margin will be imaged with SELENE and the surgeon will record the assessment and may take additional tissue (up to a maximum of six total shaves, including up to two shaves in each orientation) or record why no further tissue may be taken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of at least one unaddressed positive margin for a subject. | Within-subject comparison of the occurrence of subjects with at least one positive margin. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of unaddressed positive margins per subject. | The average number of unaddressed positive margins per subject. | 12 months | 
| False Positive Shaves Per Subject | The number of false-positive shaves per subject with use of SELENE. | 12 months |