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NCT04761055 · ClinicalTrials.gov registry record · NA
Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
A NA study of Breast Screening, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 309
- Enrollment target
- 2
- Study locations
NCT04761055: Completed NA study of Breast Screening, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04761055 is a NA study of Breast Screening that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 309 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04761055, a NA study of Breast Screening, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 309 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
Conditions Studied
Interventions
- OTHER Clinical Breast exam (CBE)
- DEVICE iBreastExam device
- DIAGNOSTIC_TEST mammogram
Study Locations (2)
New York
- MSK at Ralph Lauren (All Protocol Activities) - New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2025-08-19 |
| Phase | NA |
What the finished NCT04761055 record still lists
NCT04761055 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Breast Screening appearing as the primary indexed condition, and to 3 interventions - of which Clinical Breast exam (CBE) is the first listed.
NCT04761055 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04761055 about?
NCT04761055 is a clinical study titled "Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer". 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 dev...
What is the current status of trial NCT04761055?
This trial is currently completed. It is a NA study. The enrollment target is 309 participants. The study started on 2021-01-29. Estimated completion is 2025-08-19.
What conditions does trial NCT04761055 study?
This clinical trial studies the following conditions: Breast Screening.
What interventions are being tested in trial NCT04761055?
The interventions under investigation include: Clinical Breast exam (CBE) (OTHER), iBreastExam device (DEVICE), mammogram (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04761055?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04761055 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04761055's enrollment target sits among peer trials
309 323rd of 2000 higher than 1,678 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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