## Protocol Section
### Identification Module
**NCT ID:** NCT02207179

**Brief Title:** Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology

**Official Title:** Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology: An Ex-vivo Pilot Study of Real-time Breast Margin Imaging in Women Undergoing Breast Conservation Surgery for Early Stage Breast Cancer

#### Organization Study ID Info
**ID:** LM010
#### Organization
**Class:** INDUSTRY
**Full Name:** LumaMed
### Status Module
#### Completion Date
**Date:** 2015-11

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2015-03-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-01

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2014-08-04
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-25
**Study First Submit QC Date:** 2014-08-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Wisconsin, Madison

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** LumaMed

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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 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 Module

**Conditions:**

- Breast Cancer

**Keywords:**

- Intraoperative

- Cancer margin

- Spectroscopy

- Polarization

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** LumaScan Image Guided Surgery

**Intervention Names:**

- Device: LumaScan Image Guided Surgery

**Label:** Single Arm

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Single Arm

**Name:** LumaScan Image Guided Surgery

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins.

**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)

#### Secondary Outcomes

**Description:** The Pathologists will be asked to interpret LumaScan images and corresponding histopathology images. The images will be randomly presented to the Pathologist in order to be blinded to each.

**Measure:** Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.

**Time Frame:** From day of surgery until receipt of pathology results (upto 2 weeks)

**Description:** To correlate and determine the surgeons blinded interpretation of the LumaScan images, digital photographs vs. the final pathologic outcomes (post image acquisition)

**Measure:** Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images.

**Time Frame:** From day of surgery until receipt of pathology results (upto 2 weeks)

**Measure:** Time for each margin and bi-valved image acquisition in the operating room

**Time Frame:** Duration of surgery (upto 3 hours)

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sbambot@lumamed.com

**Name:** Shabbir B Bambot, PhD

**Phone:** 678-907-4711

**Role:** CONTACT

**Contact 2:**

**Email:** msamuels@lumamed.com

**Name:** Mark Samuels, MS

**Phone:** 404-376-6726

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madison

**Contacts:**

***Contact 1:***

- **Email:** mirrielees@surgery.wisc.edu

- **Name:** Jennifer Mirrielees, MS

- **Phone:** 608-265-1113

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Wisconsin

**State:** Wisconsin

**Status:** RECRUITING

**Zip:** 53792

#### Overall Officials

**Official 1:**

**Affiliation:** University of Wisconsin, Madison

**Name:** Lee G Wilke, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
