Wide Field OCT + AI for Breast Cancer Surgery

(RCT Trial)

No longer 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the SELENE system to assist during breast cancer surgeries. The goal is to determine if the device can better identify cancerous tissue that might remain after surgery. The trial includes two groups: one will undergo standard surgery, while the other will have surgery with the SELENE system's assistance. Women undergoing breast surgery for certain types of breast cancer, such as ductal carcinoma, might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that the SELENE system is safe for breast cancer surgery?

Research has shown that the SELENE system, which employs a special imaging technique and artificial intelligence, is generally safe for people. This imaging method has been tested in various areas, such as breast cancer surgery, and has proven safe. Participants typically tolerate it well, with few reports of side effects. As the SELENE system is a device rather than a medication, it often results in fewer side effects for participants. This makes it an appealing choice for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SELENE System because it offers a cutting-edge way to enhance breast cancer surgery. Unlike standard lumpectomy procedures, which rely on traditional methods for assessing if all cancerous tissue has been removed, the SELENE System uses a combination of wide-field Optical Coherence Tomography (OCT) and artificial intelligence (AI) to image all surgical margins in real time. This innovative approach aims to improve the accuracy of surgeries by providing detailed imaging that helps ensure no cancerous tissue is left behind, potentially reducing the need for additional surgeries and improving patient outcomes.

What evidence suggests that the SELENE system is effective for reducing unaddressed positive margins in breast lumpectomy procedures?

Research has shown that the SELENE System, which participants in this trial may receive, could enhance the effectiveness of breast cancer surgeries. Studies have demonstrated its ability to reduce the amount of cancerous tissue left behind during lumpectomies. The system employs advanced imaging and artificial intelligence to more accurately identify tumor edges. Early results suggest that SELENE can improve surgical outcomes by removing more cancerous tissue, potentially reducing the need for follow-up surgeries—a significant benefit. Overall, the SELENE System appears to improve the accuracy and success of breast cancer surgeries. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. mayo.edu mayo.edu/research/clinical-trials/cls-20550191

Wide Field OCT + AI for Positive Margin Rates in Breast ... The purpsoe of this study is to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy ...

2. bcm.edu bcm.edu/healthcare/clinical-trials/h-50099

A Trial of the Selene System in Breast Conservation Surgery This study is a randomized device trial intended for women who are planning on undergoing a lumpectomy for the treatment of invasive ductal carcinoma (IDC)

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-02224

Wide Field OCT + AI for Positive Margin Rates in Breast ... This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive ...

4. moffitt.org moffitt.org/for-healthcare-professionals/clinical-perspectives/clinical-perspectives-story-archive/innovative-margin-assessment-technology-presents-positive-outcomes-in-breast-cancer-surgery/

Innovative Margin Assessment Technology Presents ... Moffitt's Dr. Marie Lee tests the effectiveness of the SELENE System on positive margin rates in breast lumpectomy surgery for cancer.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05113927

Wide Field OCT + AI for Positive Margin Rates in Breast ... This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive ...

6. withpower.com withpower.com/trial/phase-10-2021-fbe51

Wide Field OCT + AI for Breast Cancer Surgery (RCT Trial) The studies on optical coherence tomography (OCT) systems, including those for breast cancer surgery, suggest that they are generally safe for human use. These ...