Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
Completed
- Conditions
- Breast Cancer Female
- Interventions
- Device: Investigational WF-OCT device
- Registration Number
- NCT04242277
- Lead Sponsor
- Perimeter Medical Imaging
- Brief 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.
- Detailed Description
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 198
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description WF-OCT imaging of excised breast lumpectomy tissue Investigational WF-OCT device 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.
- Primary Outcome Measures
Name Time Method WF-OCT image acquisition of excised lumpectomy tissue margins 1 year This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States