Breast Cancer Clinical Trial
— RCTOfficial 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.
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Perimeter Medical Imaging | Biostatistical Consulting, Inc., Cancer Prevention Research Institute of Texas, Proxima Clinical Research |
United States,
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 |
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