What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving breast-conserving surgery (lumpectomy) and adjuvant therapies, have several known side effects. Lumpectomy can lead to pain, swelling, and changes in breast shape. Radiation therapy, often used post-surgery, can cause skin irritation, fatigue, and in some cases, long-term changes in breast tissue. Endocrine therapies, such as tamoxifen or aromatase inhibitors, are associated with hot flashes, joint pain, and an increased risk of blood clots and bone density loss. These side effects vary in intensity and duration among patients.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including surgical techniques like lumpectomy and mastectomy, often followed by radiation therapy to reduce recurrence. Additionally, systemic therapies such as chemotherapy, hormone therapy, and targeted therapies (e.g., trastuzumab for HER2-positive breast cancer) are commonly used. While specific FDA approvals for intraoperative margin assessment systems like the SELENE system are not detailed, these technologies aim to enhance surgical precision and reduce the need for reoperations by ensuring clear margins during initial surgery.

What other types of research exist?

Promising alternatives to the SELENE system for enhanced intraoperative margin assessment in breast cancer surgery include: 1) MarginProbe, which uses electromagnetic waves to differentiate between cancerous and non-cancerous tissue; 2) Fluorescence-guided surgery, where fluorescent dyes highlight cancer cells during surgery; 3) Optical coherence tomography (OCT), providing high-resolution imaging of tissue microstructures; and 4) Molecular imaging techniques, such as using radiotracers or targeted contrast agents to identify cancerous tissues more precisely.

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

N/A

Waitlist Available

Research Sponsored by Perimeter Medical Imaging

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Age 18 years or older

Must not have

Metastatic cancer (Stage IV)

Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to index surgical visit and between 4-12 weeks post-surgical date

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As the intervention involves a diagnostic procedure rather than a drug or surgical treatment, specific side effects are not detailed like typical medication trials; however there could be general risks associated with additional imaging such as discomfort or anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am 18 years old or older.

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I am having surgery for early-stage breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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My biopsy sample was damaged before it could be imaged.

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

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I have been diagnosed with cancer in both of my breasts.

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I am male.

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My primary cancer diagnosis is lobular carcinoma.

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I have cancer in different parts of my breast but it was removed in one surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pathology report finalization date, usually 3-7 days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pathology report finalization date, usually 3-7 days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and pathology report finalization date, usually 3-7 days post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The occurrence of at least one unaddressed positive margin for a subject.

Secondary study objectives

False Positive Shaves Per Subject

Margin-level effectiveness (Histopathology)

Margin-level effectiveness (National Guidelines)

+1 more

Other study objectives

Safety Outcome - Adverse Events

Safety Outcome - Patient Reported Outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments commonly include surgery, systemic therapies, and radiation. Surgical options like lumpectomy aim to remove the tumor while preserving breast tissue, with intraoperative margin assessment (e.g., the SELENE system) ensuring all cancerous cells are excised to reduce recurrence. Systemic therapies, including chemotherapy, hormone therapy, and targeted therapy, work by attacking cancer cells throughout the body, either by killing rapidly dividing cells, blocking hormone receptors, or targeting specific molecular pathways. Radiation therapy uses high-energy rays to destroy residual cancer cells in the breast or surrounding areas. These treatments are crucial for breast cancer patients as they aim to eliminate cancer, prevent recurrence, and improve survival rates.