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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Anne Arundel Medical Center, Annapolis, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

optical coherence tomography

Device

Optical coherence tomography was used to image ex vivo breast tissue specimens.

Primary outcomes

Patients With All Positive Margins Correctly Identified With the Device

Time frame: 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

Time frame: one week after surgery

Sponsors and collaborators

Lead sponsor

Diagnostic Photonics, Inc.

Industry

Collaborators

Johns Hopkins University

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Oct 4, 2012
Registry last updated: Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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