iBreastExam Device for Breast Cancer Screening

No longer recruiting at 1 trial location

Overseen By Victoria Mango, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Male, Under 18, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the iBreastExam to determine if it can detect lumps or masses in the breast as accurately as standard breast cancer screenings. The iBreastExam is a handheld tool that provides a painless touch exam and generates a color map to highlight potential problem areas. Women over 18 visiting specific clinics for a mammogram and clinical breast exam may qualify, regardless of symptoms. As an unphased trial, this study offers participants the chance to contribute to innovative breast cancer screening technology.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device for breast cancer screening, so it's unlikely that your medications would be affected, but please confirm with the trial coordinators.

What prior data suggests that the iBreastExam device is safe for breast cancer screening?

Research has shown that the iBreastExam device is generally easy for patients to use. This handheld tool uses a gentle touch to check for unusual changes in the breast. Studies have found that it effectively identifies potential issues, though it might sometimes flag areas that are not problematic. Importantly, no serious side effects have been reported, making it a safe choice for breast cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iBreastExam device for breast cancer screening because it offers a unique, non-invasive approach to early detection. Unlike traditional methods like clinical breast exams (CBE) and mammograms, which can be uncomfortable and require specialized facilities, the iBreastExam is portable and easy to use, potentially reaching underserved communities. This device uses tactile sensor technology to detect tissue abnormalities, making it a promising tool for improving accessibility and efficiency in breast cancer screening.

What evidence suggests that the iBreastExam device is effective for breast cancer screening?

Research has shown that the iBreastExam device is promising for detecting breast abnormalities. In one study, it identified more positive results than both physical breast exams and mammograms. Another study found that the iBreastExam was more accurate in identifying breast issues than physical exams, particularly in women with non-dense breast tissue. Overall, the iBreastExam achieved a 63% success rate in detecting any breast problem, compared to 31% for physical exams. This suggests the device could be a valuable tool for early breast cancer screening. Participants in this trial will receive a breast exam using the iBreastExam device in addition to their scheduled standard clinical breast exam (CBE) and mammogram. ^{1 2 3 5 6}

Who Is on the Research Team?

Victoria Mango, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

RLC patients presenting to RLC or BAIC for mammogram and CBE

I have symptoms or no symptoms of my condition.

I am a female.

Exclusion Criteria

You are pregnant.

You are currently breastfeeding.

I am under 18 and cannot give consent on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening Visits for Breast Cancer

Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iBreastExam device

Trial Overview 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.

How Is the Trial Designed?

Group I: Screening Visits for Breast Cancer Experimental Treatment 3 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).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

UE LifeSciences Inc.

Industry Sponsor

Trials

3

Recruited

920+

Earlier.org

Collaborator

Trials

1

Recruited

310+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/GO.23.00149

Can the Clinical Utility of iBreastExam, a Novel Device, Aid ... Their study found 101 positive iBE results, 66 positive CBE results, and 35 positive mammograms results (Breast Imaging Reporting and Data ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9102465/

The iBreastExam versus clinical breast examination for ... The iBreastExam and clinical breast examination showed better sensitivity and specificity for suspicious masses in non-dense breasts compared with dense breasts ...

3. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(22)00078-X/fulltext

Breast cancer screening: can the iBreastExam bridge ... showed that the iBreastExam performed well, showing superior sensitivity over clinical breast examination for any breast lesion (63%, 95% CI 57–69 vs 31%, 25–37 ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ijc.70137

Comparison of iBreastExam with clinical breast ... We conducted a cross-sectional study to evaluate the agreement between iBreastExam (iBE) and CBE for early detection of breast cancers. Women ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)30468-5/fulltext

Non-invasive and low-cost technique for early detection of ... Conclusions: The point-of-care Breast Imaging device (iBreastExam) performed with significantly better sensitivity, by 19 %, than CBE to detect breast lesions ...

6. siemens-healthineers.com siemens-healthineers.com/en-us/accessories/ibreastexam

iBreastExam - Siemens Healthineers USA With iBreastExam, confirm and document your Clinical Breast Exams (CBEs) reliably, quickly, and painlessly... all in your office!