Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
Stopped early · Not applicable
Conditions studied: Breast Cancer Female
In brief
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 clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.
Key facts
- Study ID
- NCT04314700
- Run by
- Perimeter Medical Imaging
- People needed
- 58
- Starts
- 2020-02-11
- Expected to finish
- 2021-12-07
- Last updated by the study team
- 2023-05-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northern Arizona Healthcare — Cottonwood, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.