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OpenTrials
Completed

NCT Number: NCT04242277

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

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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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Baylor College of Medicine, Houston, Texas, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Investigational WF-OCT device

Device

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

Primary outcomes

  1. WF-OCT image acquisition of excised lumpectomy tissue margins

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Perimeter Medical Imaging

Industry

Collaborators

  • Cancer Prevention Research Institute of Texas

Registry information

Official study title

A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
May 19, 2023

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.

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