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Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology

NCT ID: NCT02207179

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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 during BCS for breast cancer. PSI uses polarized visible light for optical sectioning and geometric imaging of the superficial layers of the surgically removed tissue while rejecting surface scatter and light from deeper layers. By rejecting light from deeper tissues PSI is able to exclusively focus on the superficial tissue layers. This also results in higher resolution images than are possible with standard optical imaging. PSI is used in both reflectance and fluorescence modes. Reflectance detects morphologic abnormalities that occur in tumor progression such as increased nuclear density, angiogenesis, cellular infiltration and crowding while fluorescence detects early biochemical changes.

To enhance the contrast of tumor at the margins the investigators will use Methylene blue (MB), a dye that has been commonly used in breast surgery for mapping sentinel lymph nodes. MB can be administered peritumorally and is quickly taken up by cells in only a few minutes of exposure and its presence does not interfere with or preclude later histopathology on the same tissue specimen. A tumor specimen may also be dipped in MB post-excision to achieve tumor margin contrast enhancement and not interfere with pathologic assessment.

Previous research using PSI technology has demonstrated the value of PSI in mapping tumor boundaries of breast cancer in excised tissue specimens and in non-melanoma skin cancers and these boundaries in side by side comparisons correlate well with those marked by a pathologist on representative sections prepared using standard H\&E staining procedures.

Conditions

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Breast Cancer

Keywords

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Intraoperative Cancer margin Spectroscopy Polarization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

LumaScan Image Guided Surgery

Group Type NO_INTERVENTION

LumaScan Image Guided Surgery

Intervention Type DEVICE

Interventions

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LumaScan Image Guided Surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

LumaMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee G Wilke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shabbir B Bambot, PhD

Role: CONTACT

Phone: 678-907-4711

Email: [email protected]

Mark Samuels, MS

Role: CONTACT

Phone: 404-376-6726

Email: [email protected]

Facility Contacts

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Jennifer Mirrielees, MS

Role: primary

Other Identifiers

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LM010

Identifier Type: -

Identifier Source: org_study_id