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Device

iBreastExam Device for Breast Cancer Screening

N/A
Waitlist Available
Led By Victoria Mango, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately one month after imaging scan
Awards & highlights

Study Summary

This trial will test whether the iBreastExam can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination.

Who is the study for?
This trial is for women over 18 who can give consent and are visiting clinics for a routine breast cancer screening, which includes a mammogram and clinical breast exam. It's open to both asymptomatic and symptomatic patients. However, it excludes pregnant or lactating women, men, those under 18 or unable to consent, and anyone with non-intact skin.Check my eligibility
What is being tested?
The study is evaluating the iBreastExam device against standard breast cancer screenings like mammograms. The device uses electronic palpation to create a color map of the breast that highlights potential abnormalities needing further medical evaluation.See study design
What are the potential side effects?
Since the iBreastExam is non-invasive and performs an electronic palpation without radiation exposure or compression of the breast tissue, it's expected to have minimal side effects compared to traditional mammography.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately one month after imaging scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately one month after imaging scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results

Trial Design

1Treatment groups
Experimental Treatment
Group I: Screening Visits for Breast CancerExperimental Treatment3 Interventions
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,588 Total Patients Enrolled
UE LifeSciences Inc.Industry Sponsor
2 Previous Clinical Trials
605 Total Patients Enrolled
Earlier.orgUNKNOWN

Media Library

iBreastExam device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04761055 — N/A
Mammogram Research Study Groups: Screening Visits for Breast Cancer
Mammogram Clinical Trial 2023: iBreastExam device Highlights & Side Effects. Trial Name: NCT04761055 — N/A
iBreastExam device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04761055 — N/A

Frequently Asked Questions

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

Is enrollment available for this experiment?

"Based on the information hosted by clinicaltrials.gov, this medical trial has since ceased recruitment activities as of July 26th 2022. Nevertheless, 3 other similar research projects are still accepting candidates at present."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
65+
What site did they apply to?
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
2021. "Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04761055.
~53 spots leftby Jan 2025
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