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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-03

Study Completion Date

2021-07-27

Brief Summary

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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.

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Detailed Description

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

Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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WF-OCT imaging of excised breast lumpectomy tissue

Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired.

Investigational WF-OCT device

Intervention Type DEVICE

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

Interventions

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Investigational WF-OCT device

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

Intervention Type DEVICE

Eligibility Criteria

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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