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

Perimeter Medical Imaging

Status

Completed

Conditions

Breast Cancer

Treatments

Device: Selene

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05113927

PER-19-04

Details and patient eligibility

About

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.

Enrollment

482 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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