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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Selene

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.

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center & Research Institute
  • Pennsylvania
    • Meadowbrook, Pennsylvania, United States, 19046
      • Holy Redeemer
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center & Research Institute
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare of San Antonio
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Lumpectomy with usual intraoperative margin assessment
Experimental: Device; Imaging of all margins with investigational device	Device: Selene; 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.

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.	Pathology report finalization date, usually 3-7 days post-surgery

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.	Pathology report finalization date, usually 3-7 days post-surgery
False Positive Shaves Per Subject	The number of false-positive shaves per subject with use of SELENE.	Pathology report finalization date, usually 3-7 days post-surgery
Margin-level effectiveness (National Guidelines)	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)	Pathology report finalization date, usually 3-7 days post-surgery
Margin-level effectiveness (Histopathology)	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)	Pathology report finalization date, usually 3-7 days post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome - Adverse Events	Assessed by recording all adverse events for the duration of the study and then analyzing by seriousness, severity, and device/SELENE procedure-relatedness.	Throughout study duration
Safety Outcome - Patient Reported Outcome	Pre- and Post-operative satisfaction with breasts using the Satisfaction with Breasts subscale score of the BCT module of the patient-reported outcomes measurement instrument BREAST-Q.	Prior to index surgical visit and between 4-12 weeks post-surgical date

Collaborators and Investigators

• Sponsor: Perimeter Medical Imaging
• Collaborators: Cancer Prevention Research Institute of Texas; Biostatistical Consulting, Inc.; Proxima CRO

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: PER-19-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No