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

Perimeter Medical Imaging613 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

613

Conditions

Breast Cancer

Interventions

SeleneDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Participants With at Least One Unaddressed Positive Margin

This endpoint is a within-subject comparison of the occurrence of at least one unaddressed positive margin following standard of care (SOC) alone versus after the adjunctive use of the device (SOC + Device). An "unaddressed margin" is an actionable margin where the surgeon could have excised additional tissue but which is determined to be positive by pathology. Positive margin criteria follow NCCN and SSO/ASTRO guidelines: "ink on tumor" for invasive carcinoma and \< 2 mm for DCIS.

Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

Secondary Outcomes

The Number of Unaddressed Positive Margins Per Subject.

This measure is a within-subject comparison of the mean number of unaddressed positive margins determined through histopathology following SOC treatment alone versus SOC + Device use. An "unaddressed margin" is defined as a final margin where further tissue could have been excised but which was determined to be positive by pathology.

Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

False Positive Shaves Per Subject

A within-subject comparison of the number of "false-positive" shaves, defined as any shave where pathology reported no presence of cancer (cancer-free), taken during SOC alone vs. the supplemental use of the Device.

Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

Margin-level Effectiveness (National Guidelines)

According to the joint consensus guidelines by the Society of Surgical Oncology (SSO) and the American Society for Radiation Oncology (ASTRO), a positive margin for invasive carcinoma is defined as "ink on tumor" (1). For ductal carcinoma in situ (DCIS), including DCIS with microinvasion (DCISM), the NCCN defines a positive margin as \<2 mm and DCIS with microinvasion is further characterized as an invasive focus ≤1 mm in size) (2). For cases involving invasive carcinoma with a DCIS component, the SSO/ASTRO Guidelines apply the same definition of a positive margin-"ink on tumor"-to both invasive carcinoma and DCIS. Similarly, for participants who have undergone neo-adjuvant therapy, the "ink on tumor" definition is used for both invasive carcinoma and DCIS

Data from ClinicalTrials.gov

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