Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

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Conditions studied: Breast Cancer

In brief

This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

Key facts

Study ID

NCT02313116

Run by

Diagnostic Photonics, Inc.

People needed

50

Starts

2014-04-01

Expected to finish

2020-03-18

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women 18 years of age or older
• Signed informed consent form
• Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
• Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

You may not qualify if…

• Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Neoadjuvant systemic therapy
• All T4 tumors
• Previous radiation in the operated breast
• Prior surgical procedure in the same quadrant
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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