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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01699867
• Lead Sponsor: Diagnostic Photonics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Study Start: 2012-12
• Primary Completion: 2013-05
• Study Completion: 2014-04
• Status Verified: 2014-12
• Results First Submitted: 2014-12-05
• Results First Submitted QC: 2014-12-05
• Results First Posted: 2014-12-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients With All Positive Margins Correctly Identified With the Device	one week after surgery	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").
Number of Margins With False Positive Device Readings	one week after surgery

Trial Locations

Locations (2)

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States