for females ages 18 years and up (full criteria)
at San Francisco, California
study started
completion around
Principal Investigator
by Jasmine Wong, MD



Multi center, pivotal prospective, randomized clinical trial

The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.


ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.


Breast Cancer, lumpectomy, positive surgical margins, Breast Neoplasms, ClearEdge device


You can join if…

Open to females ages 18 years and up

  1. Patients who are female (genotype)
  2. Patients aged above 18 years, inclusive
  3. Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
  4. Patients treated with neoadjuvant endocrine therapy may be enrolled

You CAN'T join if...

  1. Patients currently receiving chemotherapy
  2. Patients having prior ipsilateral surgical treatment for breast cancer
  3. Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma)
  4. Patients who have breast implants
  5. Patients who are pregnant and/or lactating
  6. Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.


  • UCSF Medical Center at Mission Bay accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Jasmine Wong, MD
    Associate Professor, Surgery, School of Medicine. Authored (or co-authored) 12 research publications


accepting new patients
Start Date
Completion Date
LS BioPath
Study Type
Expecting 288 study participants
Last Updated