Status:
UNKNOWN
Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology
Lead Sponsor:
LumaMed
Collaborating Sponsors:
University of Wisconsin, Madison
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
This study will evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surger...
Detailed Description
LumaScan is an innovative polarization microscope that uses Polarization Subtraction Imaging (PSI) technology to provide real time, intra operative, digital images of the surface of tissue removed dur...
Eligibility Criteria
Inclusion
- Women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).
- 18 years of age or older.
- Able to read or understand and give informed consent.
Exclusion
- Patients undergoing neo-adjuvant systemic therapy.
- Previous breast cancer and /or radiation in the operated breast.
- Implants in the operated breast.
- Pregnant or Lactating.
- History of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye.
- Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
- Participation in any other intraoperative margin assessment protocol that would affect data acquisition.
- Subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
- Patients for whom English is not their native language
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02207179
Start Date
January 1 2014
End Date
November 1 2015
Last Update
March 31 2015
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792