Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Multi-center, randomized, double-arm trial
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
The pathologist at each participating site will be blinded to the study arm to ensure that the pathological assessment is unbiased. Additionally, the subject will be blinded to their randomization until the BREAST-Q questionnaire has been completed.

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of Care
Lumpectomy with usual intraoperative margin assessment
Experimental
Device
Imaging of all margins with investigational device
  • 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.

Recruiting Locations

St. David's Georgetown Hospital
Georgetown, Texas 78626
Contact:
Krishna Saini
512-544-8070
krishna.saini@stdavids.com

More Details

Status
Recruiting
Sponsor
Perimeter Medical Imaging

Study Contact

Sarah Butler, PhD
937.416.9886
sbutler@perimetermed.com

Detailed Description

Optical coherence tomography (OCT) -- the optical analogue of high-frequency ultrasound -- is well suited for operative suite decision making because it offers real-time, high-resolution tissue imaging with a penetration depth up to 2 mm. The 2 mm depth of penetration is sufficient to accommodate the current national US (and international) guidelines which state that following resection there should be no tumor "on ink" for invasive cancer and not less than a 2 mm margin for DCIS in the absence of invasive disease. Recently, automated image analysis has demonstrated the potential to both improve diagnostic accuracy and reduce overall assessment time. OCT combined with deep learning algorithms has the potential to aid surgeons in identifying regions of interest on scanned samples, enabling them to make key decisions on margin status intraoperatively.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.