NCT02207179

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 breast-cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

March 25, 2014

Last Update Submit

March 30, 2015

Conditions

Breast Cancer

Keywords

IntraoperativeCancer marginSpectroscopyPolarization

Outcome Measures

Primary Outcomes (1)

  • Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images.

    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.

    From day of surgery until receipt of pathology results (upto 2 weeks)

Secondary Outcomes (3)

  • Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.

    From day of surgery until receipt of pathology results (upto 2 weeks)

  • Surgeons interpretation of LumaScan images (blinded) are similar to those of histopathology images.

    From day of surgery until receipt of pathology results (upto 2 weeks)

  • Time for each margin and bi-valved image acquisition in the operating room

    Duration of surgery (upto 3 hours)

Study Arms (1)

Single Arm

NO INTERVENTION

LumaScan Image Guided Surgery

Device: LumaScan Image Guided Surgery

Interventions

LumaScan Image Guided SurgeryDEVICE
Single Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lee G Wilke, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shabbir B Bambot, PhD

CONTACT

678-907-4711sbambot@lumamed.com

Mark Samuels, MS

CONTACT

404-376-6726msamuels@lumamed.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

August 4, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

US(1)