Recruiting
Early Phase 1

Breast Cancer

Sponsor:

LumaMed

Code:

NCT02207179

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

LumaScan Image Guided Surgery

Study Details

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 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.

Conditions

Breast Cancer

Study ID

NCT02207179

Start date

Jan, 2014

Status verified date

Mar, 2015

Completion date

Nov, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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).
2. 18 years of age or older.
3. Able to read or understand and give informed consent.

Exclusion Criteria:

1. Patients undergoing neo-adjuvant systemic therapy.
2. Previous breast cancer and /or radiation in the operated breast.
3. Implants in the operated breast.
4. Pregnant or Lactating.
5. History of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye.
6. Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
7. Participation in any other intraoperative margin assessment protocol that would affect data acquisition.
8. Subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
9. Patients for whom English is not their native language

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Single Arm

LumaScan Image Guided Surgery

Interventions

LumaScan Image Guided Surgery

Primary outcome measure

  • Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images. [ Time Frame: From day of surgery until receipt of pathology results (upto 2 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

More Information

Sponsor

LumaMed

Last update posted

Mar 31, 2015

Last verified

Mar, 2015

Keywords

  • Intraoperative
  • Cancer margin
  • Spectroscopy
  • Polarization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LumaMed on 2015-03-31.