Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Optical coherence tomography

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer undergoing lumpectomy

Description

Inclusion Criteria:

1. Women 18 years of age or older
2. Signed informed consent form
3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With All Positive Margins Correctly Identified With the Device	In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").	one week after surgery
Number of Margins With False Positive Device Readings		one week after surgery

Collaborators and Investigators

• Sponsor: Diagnostic Photonics, Inc.
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Lisa K Jacobs, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 2, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: breast cancer; imaging; optical coherence tomography; lumpectomy; tumor margin
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DxP 2012-02 (Part A)