Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology
Status unconfirmed · Early Phase 1
Conditions studied: Breast Cancer
In brief
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 Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
Key facts
- Study ID
- NCT02207179
- Run by
- LumaMed
- People needed
- 40
- Starts
- 2014-01-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2015-03-31
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Wisconsin — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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