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

Perimeter Medical Imaging

Status: Completed

Conditions: Breast Cancer Female

Treatments: Device: Investigational WF-OCT device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04242277

PER-19-03

Details and patient eligibility

About

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.

Full description

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

Enrollment: 198 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

198 participants in 1 patient group

WF-OCT imaging of excised breast lumpectomy tissue

Description:

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.

Treatment:

Device: Investigational WF-OCT device