Status:
TERMINATED
Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
Lead Sponsor:
Perimeter Medical Imaging
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain...
Detailed Description
Note: A retrospective review of the stated purpose and objectives of the PER-19-02 protocol has determined that this study better fits the definition of a medical device feasibility study, with regard...
Eligibility Criteria
Inclusion
- Female age 18 or older
- Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal or lobular breast carcinoma and/or ductal carcinoma in situ
- May include subjects treated with neo-adjuvant endocrine therapy
- May include subjects treated with neo-adjuvant chemotherapy with confirmed complete clinical response
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Male
- Stage IV breast cancer
- Participation in another study that prolongs time to pathologic processing (greater than 1 hour)
- Neo-adjuvant treated patients with any chemotherapeutic who have not achieved a complete clinical response
- A surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon's intraoperative decision will not be used in the data analysis of this study. These subjects will be replaced in the study and the surgeon's intraoperative decision to conduct a frozen section analysis will be recorded).
- Use of cryosurgery
- Currently lactating
- Current pregnancy
- Previous ipsilateral breast surgery for benign or malignant disease in the same quadrant as currently planned surgery
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04314700
Start Date
February 11 2020
End Date
December 7 2021
Last Update
May 26 2023
Active Locations (1)
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1
Northern Arizona Healthcare
Cottonwood, Arizona, United States, 86326