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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Device: Investigational WF-OCT device

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consented patients meeting eligibility criteria, undergoing breast conservation surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Investigational WF-OCT device; Excised lumpectomy tissue will be imaged on an investigational WF-OCT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Perimeter Medical Imaging
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Savitri Krishnamurthy, MD, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): July 27, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PER-19-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No