Real Time Optical Coherence Tomography (OCT) of Human Tissue
18 Years
N/A
Female
Breast Cancer
Trial Information
Real Time Optical Coherence Tomography (OCT) of Human Tissue
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 lumpectomy will be recruited by the clinical investigators at the investigational
site in accordance with the inclusion and exclusion criteria. The study period per subject
is the time it takes to assess the in vivo and ex vivo breast tissue samples using the study
device during their lumpectomy.
All specimens will be marked with India ink and undergo standard post-operative histology,
and digital histology images corresponding to the inked locations will be obtained. The
images and the matched digitized post-operative histology images will then be randomized and
read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.
Inclusion Criteria:
1. Women 18 years of age or older
2. Signed ICF
3. Women who have been histologically diagnosed with invasive ductal carcinoma or
invasive lobular carcinoma of the breast prior to surgery
4. Planning breast preservation
5. Patients 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions.
Outcome Time Frame:
One week after surgery
Safety Issue:
No
Principal Investigator
Stephen A Boppart, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Illinois and Diagnostic Photonics, Inc.
Authority:
United States: Institutional Review Board
Study ID:
DXP 2012-01
NCT ID:
NCT01506700
Start Date:
May 2012
Completion Date:
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Carle Foundation Hospital | Urbana, Illinois 61801 |
