Wide Field OCT + AI for Breast Cancer Surgery
(RCT Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Perimeter Medical Imaging

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests the SELENE system, a new tool used during breast cancer surgery. It aims to help surgeons make sure they remove all cancerous tissue. The study focuses on patients having breast lumpectomies to reduce the chances of leaving any cancer behind.

Eligibility Criteria

This trial is for women aged 18 or older with Stage 0-III invasive ductal and/or ductal carcinoma in situ undergoing breast conservation surgery. It's open to those who may have had neo-adjuvant therapy. Exclusions include lactating women, bilateral disease, damaged specimen margins, lobular carcinoma as primary diagnosis, previous ipsilateral breast surgery, multicentric disease not resected in one piece, other investigational studies participation, metastatic cancer (Stage IV), current pregnancy or being male.

Inclusion Criteria

I may have had hormone or chemotherapy before surgery, but it's not a must for joining.

Ability to understand and the willingness to sign a written informed consent document

I am female.

+2 more

Exclusion Criteria

My cancer has spread to other parts of my body.

My biopsy sample was damaged before it could be imaged.

I had breast surgery or implants within the last two years.

+8 more

Participant Groups

The study tests the SELENE system's effectiveness alongside standard intraoperative margin assessment to reduce unaddressed positive margins during lumpectomy procedures for breast cancer. This multi-center trial randomly assigns participants into two groups: one using SELENE plus standard care and another receiving only standard care.

2Treatment groups

Experimental Treatment

Active Control

Group I: DeviceExperimental Treatment1 Intervention

Imaging of all margins with investigational device

Group II: Standard of CareActive Control1 Intervention

Lumpectomy with usual intraoperative margin assessment