Status:
SUSPENDED
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Lead Sponsor:
Diagnostic Photonics, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 18 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02313116
Start Date
April 1 2014
End Date
March 18 2020
Last Update
July 18 2019
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231