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Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

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ClinicalTrials.gov Identifier: NCT04761055
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
UE LifeSciences Inc.
Earlier.org
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Screening Other: Clinical Breast exam (CBE) Device: iBreastExam device Diagnostic Test: mammogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Other: Clinical Breast exam (CBE)
The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.

Device: iBreastExam device
The iBE is an FDA 510(k) cleared portable device which utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities. The iBE exam will be administered by a mammogram technologist, blinded to CBE results.

Diagnostic Test: mammogram
All patients will have routine standard mammographic views performed. Patients with positive iBE and/or CBE findings will have additional mammographic and/or ultrasound imaging to determine if a correlating breast lesion is present using the same standard of care algorithm as is used currently for positive CBE findings.




Primary Outcome Measures :
  1. Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results [ Time Frame: approximately one month after imaging scan ]
    comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE

  2. Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results [ Time Frame: approximately one month after imaging scan ]
    comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patient
  • Over 18 years of age, able to consent
  • RLC patients presenting to RLC or BAIC for mammogram and CBE
  • Asymptomatic and symptomatic patients will be included

Exclusion Criteria:

  • Male patients
  • Patients under 18 years of age, unable to consent
  • Pregnant patients
  • Lactating patients
  • Non-intact skin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761055


Contacts
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Contact: Victoria Mango, MD 646-888-4622 mangov@mskcc.org
Contact: Delia Keating, MD 646-888-5224

Locations
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United States, New York
MSK at Ralph Lauren (All Protocol Activities) Recruiting
New York, New York, United States, 10035
Contact: Victoria Mango, MD    646-888-4622      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Victoria Mango, MD    646-888-4622      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
UE LifeSciences Inc.
Earlier.org
Investigators
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Principal Investigator: Victoria Mango, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04761055    
Other Study ID Numbers: 19-302
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast Abnormalities