NCT02313116SuspendedNot Applicable
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Diagnostic Photonics, Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Patients With All Positive/Close Margins Correctly Identified With the Device
Study Overview
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Outcomes
Primary Outcomes
Patients With All Positive/Close Margins Correctly Identified With the Device
Time Frame: 1 week after surgery
Number of Margins With False Positive Device Readings
Time Frame: 1 week after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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