Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
- Conditions
- Breast Cancer
- Interventions
- Device: Selene
- Registration Number
- NCT05113927
- Lead Sponsor
- Perimeter Medical Imaging
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 482
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device Selene Imaging of all margins with investigational device
- Primary Outcome Measures
Name Time Method The occurrence of at least one unaddressed positive margin for a subject. Pathology report finalization date, usually 3-7 days post-surgery Within-subject comparison of the occurrence of subjects with at least one positive margin.
- Secondary Outcome Measures
Name Time Method False Positive Shaves Per Subject Pathology report finalization date, usually 3-7 days post-surgery The number of false-positive shaves per subject with use of SELENE.
Margin-level effectiveness (Histopathology) Pathology report finalization date, usually 3-7 days post-surgery Margin-level effectiveness of SELENE based on recorded clinical decisions with "ground truth" determined based on histopathological presence of disease at 2 mm or less based on visible tissue depth using OCT (device arm Part B only- all margins)
The number of unaddressed positive margins per subject. Pathology report finalization date, usually 3-7 days post-surgery The average number of unaddressed positive margins per subject.
Margin-level effectiveness (National Guidelines) Pathology report finalization date, usually 3-7 days post-surgery Margin-level effectiveness of SELENE based on recorded clinical decisions with "ground truth" determined based on National Comprehensive Cancer Network (NCCN), Society of Surgical Oncology (SSO), and the American Society for Radiation Oncology (ASRO) Guidelines (device arm Part B only- all margins)
Trial Locations
- Locations (10)
Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Holy Redeemer
🇺🇸Meadowbrook, Pennsylvania, United States
West Cancer Center & Research Institute
🇺🇸Germantown, Tennessee, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Methodist Healthcare of San Antonio
🇺🇸San Antonio, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States