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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
Timeline
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 belowSelect...
I am female.
Select...
I am 18 years old or older.
Select...
I am having surgery for early-stage breast cancer.
RCT Trial 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
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 moreOther 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have had hormone or chemotherapy before surgery, but it's not a must for joining.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.I have been diagnosed with cancer in both of my breasts.I am male.I am female.My primary cancer diagnosis is lobular carcinoma.I am 18 years old or older.I am having surgery for early-stage breast cancer.I have cancer in different parts of my breast but it was removed in one surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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