Breast Cancer Female
Conditions
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.
Interventions
DEVICEInvestigational WF-OCT device
Excised lumpectomy tissue will be imaged on an investigational WF-OCT device
Sponsors
Cancer Prevention Research Institute of Texas
Perimeter Medical Imaging
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed