Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Lumpectomy, Breast cancer, Optical coherence tomography, Tumor margin, Imaging
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Interferometric Synthetic Aperture Microscopy
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Johns Hopkins Hospital
Baltimore, Maryland, United States
Status: Recruiting
Contact: Dene Palazzi - 443-287-8610 - dnoppen1@jhmi.edu
Start Date
April 2014
Completion Date
February 2015
Sponsors
Diagnostic Photonics, Inc.
Source
Diagnostic Photonics, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page