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NCT04242277 Clinical Trial

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

Breast Cancer Female Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04242277
Other study ID # PER-19-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2020
Est. completion date July 27, 2021

Study information
Verified date May 2023
Source Perimeter Medical Imaging
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date July 27, 2021
Est. primary completion date July 27, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Investigational WF-OCT device
Excised lumpectomy tissue will be imaged on an investigational WF-OCT device

Locations
Country Name City State
United States Baylor College of Medicine Houston Texas
United States MD Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
Perimeter Medical Imaging Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year
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