Wide Field OCT + AI for Breast Cancer Surgery

(RCT Trial)

Recruiting at 11 trial locations

Overseen By Sarah Butler, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Perimeter Medical Imaging

Disqualifiers: Metastatic cancer, Lobular carcinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day (surgery)

482 Participants Needed

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants may have been treated with certain therapies before joining the study, so it's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment SELENE System in the clinical trial 'Wide Field OCT + AI for Breast Cancer Surgery'?

Research shows that using optical coherence tomography (OCT) with artificial intelligence (AI) can accurately differentiate between healthy and cancerous breast tissues during surgery, with accuracy rates as high as 96.7% in some studies. This suggests that the SELENE System, which likely uses similar technology, could be effective in improving breast cancer surgery outcomes by helping surgeons identify cancerous tissues more precisely. ^{1 2 3 4 5}

Is the Wide Field OCT + AI system safe for use in humans?

The studies on optical coherence tomography (OCT) systems, including those for breast cancer surgery, suggest that they are generally safe for human use. These systems have been used in various studies to provide real-time imaging during surgery, and no safety concerns have been reported in the research provided. ^{1 2 6 7 8}

How does the Wide Field OCT + AI treatment for breast cancer surgery differ from other treatments?

The Wide Field OCT + AI treatment is unique because it uses optical coherence tomography (OCT) combined with artificial intelligence to provide real-time imaging and analysis during breast cancer surgery. This approach helps surgeons accurately identify cancerous tissue and differentiate it from healthy tissue, potentially improving surgical outcomes by ensuring more precise removal of tumors. ^{1 2 5 9 10}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast lumpectomy with either standard intraoperative margin assessment or additional imaging with the SELENE system

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including pathology report finalization and patient-reported outcomes

4-12 weeks

2-3 visits (in-person)

Treatment Details

Interventions

• SELENE System

Trial Overview 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.

Participant Groups

Group I: Device Experimental Treatment 1 Intervention

Imaging of all margins with investigational device

Group II: Standard of Care Active Control 1 Intervention

Lumpectomy with usual intraoperative margin assessment

Who Is Running the Clinical Trial?

Perimeter Medical Imaging

Lead Sponsor

Trials

3

Recruited

740+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Proxima Clinical Research

Collaborator

Trials

3

Recruited

580+

Biostatistical Consulting, Inc.

Collaborator

Trials

3

Recruited

750+

Proxima CRO

Industry Sponsor

Trials

5

Recruited

830+

References

1. United States pubmed.ncbi.nlm.nih.gov

Complementary use of polarization-sensitive and standard OCT metrics for enhanced intraoperative differentiation of breast cancer. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Classifying breast cancer in ultrahigh-resolution optical coherence tomography images using convolutional neural networks. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Differentiation of breast tissue types for surgical margin assessment using machine learning and polarization-sensitive optical coherence tomography. [2021]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Multimodal Optical Coherence Tomography for Intraoperative Evaluation of Tumor Margins and Surgical Margins in Breast-Conserving Surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Extravascular optical coherence tomography of cerebral vessel walls in vivo. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Real-time Imaging of the Resection Bed Using a Handheld Probe to Reduce Incidence of Microscopic Positive Margins in Cancer Surgery. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Intraoperative evaluation of breast tumor margins with optical coherence tomography. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Detection of breast surgical margins with optical coherence tomography imaging: a concept evaluation study. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Delineating breast ductal carcinoma using combined dye-enhanced wide-field polarization imaging and optical coherence tomography. [2013]

10. Germany pubmed.ncbi.nlm.nih.gov

Intraoperative application of optical coherence tomography for lung tumor. [2023]