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



Status:Suspended
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/9/2018
Start Date:April 2014
End Date:February 2019

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Trial Summary
Trial Overview
Inclusion Criteria
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.


Inclusion Criteria:

1. Women 18 years of age or older

2. Signed informed consent form

3. Women who have been histologically diagnosed with carcinoma of the breast prior to
surgery

4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy)
procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of
the breast)

2. Neoadjuvant systemic therapy

3. All T4 tumors

4. Previous radiation in the operated breast

5. Prior surgical procedure in the same quadrant

6. Implants in the operated breast

7. Pregnancy

8. Lactation

9. Participating in any other investigational study for either drug or device which can
influence collection of valid data under this study
We found this trial at
1
site
Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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