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

NCT05113927 | Completed FDA Device

• 1 other identifier: PER-19-04
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The number of unaddressed positive margins per subject.

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

• False Positive Shaves Per Subject

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

• Margin-level effectiveness (National Guidelines)

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

• Margin-level effectiveness (Histopathology)

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

Other Outcomes (2)

• Safety Outcome - Adverse Events

  Throughout study duration

• Safety Outcome - Patient Reported Outcome

  Prior to index surgical visit and between 4-12 weeks post-surgical date

Study Arms (2)

Standard of Care

NO INTERVENTION

Lumpectomy with usual intraoperative margin assessment

Device

EXPERIMENTAL

Imaging of all margins with investigational device

Device: Selene

Interventions

Selene DEVICE

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.

Device

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Perimeter Medical Imaging: lead
• Cancer Prevention Research Institute of Texas: collaborator
• Proxima CRO: collaborator
• Biostatistical Consulting, Inc.: collaborator

Study Sites (10)

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Holy Redeemer

Meadowbrook, Pennsylvania, 19046, United States

Location

West Cancer Center & Research Institute

Germantown, Tennessee, 38138, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Methodist Healthcare of San Antonio

San Antonio, Texas, 78229, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The pathologist at each participating site will be blinded to the study arm to ensure that the pathological assessment is unbiased. Additionally, the subject will be blinded to their randomization until the BREAST-Q questionnaire has been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized, double-arm trial

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 9, 2021
• Study Start: December 1, 2021
• Primary Completion: September 23, 2024
• Study Completion: October 21, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)