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

Diagnostic Photonics, Inc.50 enrolled

Overview

This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

Interferometric Synthetic Aperture MicroscopyDEVICE

Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Patients With All Positive/Close Margins Correctly Identified With the Device

Time frame: 1 week after surgery

Number of Margins With False Positive Device Readings

Time frame: 1 week after surgery

Data from ClinicalTrials.gov

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