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

NACompletedINTERVENTIONAL
Enrollment

482

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

September 23, 2024

Study Completion Date

October 21, 2024

Conditions
Breast Cancer
Interventions
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.

Trial Locations (10)

19046

Holy Redeemer, Meadowbrook

32207

Baptist MD Anderson Cancer Center, Jacksonville

32224

Mayo Clinic, Jacksonville

33612

Moffitt Cancer Center & Research Institute, Tampa

38138

West Cancer Center & Research Institute, Germantown

53792

University of Wisconsin, Madison

75230

Medical City Dallas, Dallas

77030

Baylor College of Medicine, Houston

78229

Methodist Healthcare of San Antonio, San Antonio

98195

University of Washington, Seattle

Sponsors
All Listed Sponsors
collaborator

Cancer Prevention Research Institute of Texas

OTHER

collaborator

Proxima CRO

INDUSTRY

collaborator

Biostatistical Consulting, Inc.

OTHER

lead

Perimeter Medical Imaging

INDUSTRY

NCT05113927 - Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery. | Biotech Hunter | Biotech Hunter