Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-003734
NCT ID: NCT05113927
Sponsor Protocol Number: PER-19-04
About this study
The purpsoe of this study is 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 (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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/6/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator James Jakub, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available