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

Research Sponsored by Perimeter Medical Imaging
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Screening 3 weeks
Treatment Varies
Follow Up prior to index surgical visit and between 4-12 weeks post-surgical date
Awards & highlights

RCT Trial 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.

RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am female.
I am 18 years old or older.
I am having surgery for early-stage breast cancer.

RCT Trial 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

RCT 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

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
97,907 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are administering this experiment?

"This clinical trial is taking place at 8 different centres, including the Moffitt Cancer Center & Research Institute in Tampa and Holy Redeemer in Meadowbrook. Other sites include St. David's Georgetown Hospital in Georgetown and several other locations."

Answered by AI

How many individuals are being recruited for this trial?

"Affirmative. The details of this clinical trial, which were initially added to clinicaltrials.gov on December 1st 2021, confirm that it is currently recruiting patients. Across 8 sites a total 333 participants are being sought for the study."

Answered by AI

Are there any current opportunities to participate in this trial?

"According to the records hosted on clinicaltrials.gov, this study is still recruiting participants. The original posting went live in December 2021 and was last updated in October 2022."

Answered by AI
~78 spots leftby Oct 2024