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

Breast Cancer Clinical Trial

— RCT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113927
• Other study ID #: PER-19-04
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Perimeter Medical Imaging
• Contact: Sarah Butler, PhD
• Phone: 937.416.9886
• Email: sbutler[@]perimetermed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 531
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Medical City Dallas	Dallas	Texas
United States	West Cancer Center & Research Institute	Germantown	Tennessee
United States	Baylor College of Medicine	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	Holy Redeemer	Meadowbrook	Pennsylvania
United States	Methodist Healthcare of San Antonio	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Perimeter Medical Imaging	Biostatistical Consulting, Inc., Cancer Prevention Research Institute of Texas, Proxima Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome - Adverse Events	Assessed by recording all adverse events for the duration of the study and then analyzing by seriousness, severity, and device/SELENE procedure-relatedness.	Throughout study duration
Other	Safety Outcome - Patient Reported Outcome	Pre- and Post-operative satisfaction with breasts using the Satisfaction with Breasts subscale score of the BCT module of the patient-reported outcomes measurement instrument BREAST-Q.	Prior to index surgical visit and between 4-12 weeks post-surgical date
Primary	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	The number of unaddressed positive margins per subject.	The average number of unaddressed positive margins per subject.	Pathology report finalization date, usually 3-7 days post-surgery
Secondary	False Positive Shaves Per Subject	The number of false-positive shaves per subject with use of SELENE.	Pathology report finalization date, usually 3-7 days post-surgery
Secondary	Margin-level effectiveness (National Guidelines)	Margin-level effectiveness of SELENE based on recorded clinical decisions with "ground truth" determined based on National Comprehensive Cancer Network (NCCN), Society of Surgical Oncology (SSO), and the American Society for Radiation Oncology (ASRO) Guidelines (device arm Part B only- all margins)	Pathology report finalization date, usually 3-7 days post-surgery
Secondary	Margin-level effectiveness (Histopathology)	Margin-level effectiveness of SELENE based on recorded clinical decisions with "ground truth" determined based on histopathological presence of disease at 2 mm or less based on visible tissue depth using OCT (device arm Part B only- all margins)	Pathology report finalization date, usually 3-7 days post-surgery