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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05113927

Run by

Perimeter Medical Imaging

People needed

613

Starts

2021-12-01

Expected to finish

2024-10-21

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Moffitt Cancer Center & Research Institute — Tampa, 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

Full record on ClinicalTrials.gov

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