Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.

Perimeter Medical Imaging198 enrolled

Overview

This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.

Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.

Study Type

OBSERVATIONAL

Enrollment

198

Conditions

Breast Cancer Female

Interventions

Investigational WF-OCT deviceDEVICE

Excised lumpectomy tissue will be imaged on an investigational WF-OCT device

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * Age 18 years or older * Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery * May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Metastatic cancer (Stage IV) * Lobular carcinoma as primary diagnosis

Locations (2)

Baylor College of Medicine

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

WF-OCT image acquisition of excised lumpectomy tissue margins

This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.

Time frame: 1 year

Data from ClinicalTrials.gov

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