Status:
TERMINATED
Real Time Optical Coherence Tomography (OCT) of Human Tissue
Lead Sponsor:
Diagnostic Photonics, Inc.
Collaborating Sponsors:
University of Illinois at Chicago
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on ...
Detailed Description
This study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to undergo a lumpecto...
Eligibility Criteria
Inclusion
- Women 18 years of age or older
- Signed ICF
- Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery
- Planning breast preservation
- Patients 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 :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01506700
Start Date
May 1 2012
End Date
July 17 2019
Last Update
July 26 2019
Active Locations (1)
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1
Carle Foundation Hospital
Urbana, Illinois, United States, 61801