Clinical Trial 21937

• Overview

  Study 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

  Summary:

  This study is 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.

  Objective:

  STUDY OBJECTIVE: To measure the effectiveness of adjunctive SELENE use as compared to lumpectomy standard of care in addressing positive margins.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Standard of Care ()

• 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

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