Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
NCT ID: NCT05113927
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
482 participants
INTERVENTIONAL
2021-12-01
2024-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard of Care
Lumpectomy with usual intraoperative margin assessment
No interventions assigned to this group
Device
Imaging of all margins with investigational 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
Proxima CRO
INDUSTRY
Biostatistical Consulting, Inc.
OTHER
Perimeter Medical Imaging
INDUSTRY
Responsible Party
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Locations
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Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Holy Redeemer
Meadowbrook, Pennsylvania, United States
West Cancer Center & Research Institute
Germantown, Tennessee, United States
Medical City Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Methodist Healthcare of San Antonio
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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PER-19-04
Identifier Type: -
Identifier Source: org_study_id