← Back to Search

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

N/A
Recruiting
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

Summary

This trial will test a new system to see if it can reduce the number of positive margins in breast lumpectomy procedures.

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.Check my eligibility
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.See study design
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
Select...
I am female.
Select...
I am 18 years old or older.
Select...
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:
Select...
My cancer has spread to other parts of my body.
Select...
My biopsy sample was damaged before it could be imaged.
Select...
I had breast surgery or implants within the last two years.
Select...
I have been diagnosed with cancer in both of my breasts.
Select...
I am male.
Select...
My primary cancer diagnosis is lobular carcinoma.
Select...
I have cancer in different parts of my breast but it was removed in one surgery.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The occurrence of at least one unaddressed positive margin for a subject.
Secondary outcome measures
False Positive Shaves Per Subject
Margin-level effectiveness (Histopathology)
Margin-level effectiveness (National Guidelines)
+1 more
Other outcome measures
Safety Outcome - Adverse Events
Safety Outcome - Patient Reported Outcome

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

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.

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
51 Previous Clinical Trials
98,507 Total Patients Enrolled
7 Trials studying Breast Cancer
18,374 Patients Enrolled for Breast Cancer
Proxima Clinical ResearchUNKNOWN
1 Previous Clinical Trials
66 Total Patients Enrolled
Biostatistical Consulting, Inc.OTHER
2 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

Selene Clinical Trial Eligibility Overview. Trial Name: NCT05113927 — N/A
Breast Cancer Research Study Groups: Standard of Care, Device
Breast Cancer Clinical Trial 2023: Selene Highlights & Side Effects. Trial Name: NCT05113927 — N/A
Selene 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113927 — N/A
~31 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top