Clinical trial NCT05113927: Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
Official title: A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Perimeter Medical Imaging
Sponsor class: INDUSTRY
Collaborators: name: Cancer Prevention Research Institute of Texas
name: Proxima CRO
name: Biostatistical Consulting, Inc.
First posted: 2021-11-09
Enrollment: 482
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, randomized, double-arm trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The occurrence of at least one unaddressed positive margin for a subject.
timeFrame: Pathology report finalization date, usually 3-7 days post-surgery
Secondary outcomes:
measure: The number of unaddressed positive margins per subject.
timeFrame: Pathology report finalization date, usually 3-7 days post-surgery
measure: False Positive Shaves Per Subject
timeFrame: Pathology report finalization date, usually 3-7 days post-surgery
measure: Margin-level effectiveness (National Guidelines)
timeFrame: Pathology report finalization date, usually 3-7 days post-surgery
measure: Margin-level effectiveness (Histopathology)
timeFrame: Pathology report finalization date, usually 3-7 days post-surgery
Other outcomes:
measure: Safety Outcome - Adverse Events
timeFrame: Throughout study duration
measure: Safety Outcome - Patient Reported Outcome
timeFrame: Prior to index surgical visit and between 4-12 weeks post-surgical date
Locations:
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center &amp; Research Institute
state: Florida
city: Meadowbrook
country: United States
facility: Holy Redeemer
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center & Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare of San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: