Breast Cancer Clinical Trial
Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
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.
Full 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.
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 (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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 7 Locations for this study
Tampa Florida, 33612, United States More Info
Principal Investigator
Sub-Investigator
Meadowbrook Pennsylvania, 19046, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Germantown Tennessee, 38138, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Georgetown Texas, 78626, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
San Antonio Texas, 78229, United States More Info
Principal Investigator
Madison Wisconsin, 53792, United States More Info
Principal Investigator
Sub-Investigator
How clear is this clinincal trial information?