iBreastExam Device for Breast Cancer Screening

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

310 Participants Needed

Trial Summary

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 data supports the effectiveness of the iBreastExam device for breast cancer screening?

The research highlights the effectiveness of mammography in detecting breast cancer early, which is crucial for successful treatment. Although the iBreastExam device is not specifically mentioned, the general principle of early detection improving outcomes supports the potential value of any effective breast cancer screening tool. ^{1 2 3 4 5}

How does the iBreastExam device differ from other breast cancer screening treatments?

The iBreastExam device is unique because it is a handheld scanner that electronically palpates the breast to detect abnormalities, making it suitable for use by community health workers in low-resource settings. Unlike traditional mammography, it does not require radiation or complex equipment, offering a more accessible and cost-effective option for early breast cancer detection. ^{6 7 8 9 10}

What is the purpose of this trial?

This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.

Research Team

Victoria Mango, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Spain pubmed.ncbi.nlm.nih.gov

[The evolution of breast cancer mortality and the dissemination of mammography in Catalonia: an analysis by health region]. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Time for a re-evaluation of mammography in the young? Results of an audit of mammography in women younger than 40 in a resource restricted environment. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Screening for breast cancer with mammography. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Mammography Adherence: Creation of a Process Change Plan to Increase Usage Rates. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

Quality assurance in Mammography: An overview. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A cost-effective handheld breast scanner for use in low-resource environments: a validation study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The iBreastExam versus clinical breast examination for breast evaluation in high risk and symptomatic Nigerian women: a prospective study. [2023]

8. Greece pubmed.ncbi.nlm.nih.gov

Breast cancer in European Union: an update of screening programmes as of March 2014 (review). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Emerging technologies in breast cancer detection. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Breast cancer screening (BCS) chart: a basic and preliminary model for making screening mammography more productive and efficient. [2019]