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NCT04764292 · ClinicalTrials.gov registry record · Phase 4
Screening Contrast-Enhanced Mammography as an Alternative to MRI
A Phase 4 study, sponsored by Wendie Berg.
- Completed
- Registry status
- Phase 4
- Development phase
- 615
- Enrollment target
NCT04764292: Completed Phase 4 study, sponsored by Wendie Berg.
NCT04764292 is a Phase 4 study that has completed, run by Wendie Berg. The registered enrollment target is 615 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04764292, a Phase 4 study, has completed, sponsored by Wendie Berg.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 615 participants
- Enrollment target
Study Summary
There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.
Primary Outcome
Cancer detection rate per 1,000 screenings with CEM compared to standard mammography/tomosynthesis (DBT) alone. Interpretation and performance outcomes from the primary reader were compared between standard-of-care DBT examinations interpreted alone and DBT examinations interpreted with the addition of CEM.
Interventions
- DRUG Iodinated Contrast Media (ICM)
- DEVICE Contrast-enhanced mammography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 615 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2025-05-30 |
| Phase | Phase 4 |
What the finished NCT04764292 record still lists
NCT04764292 is an interventional study that assigns participants to a tested intervention. The registered 615 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 2 interventions - of which Iodinated Contrast Media (ICM) is the first listed.
NCT04764292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04764292 about?
NCT04764292 is a clinical study titled "Screening Contrast-Enhanced Mammography as an Alternative to MRI". There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screenin...
What is the current status of trial NCT04764292?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 615 participants. The study started on 2021-02-15. Estimated completion is 2025-05-30.
What interventions are being tested in trial NCT04764292?
The interventions under investigation include: Iodinated Contrast Media (ICM) (DRUG), Contrast-enhanced mammography (DEVICE).
Who is sponsoring clinical trial NCT04764292?
This trial is sponsored by Wendie Berg, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04764292's enrollment target sits among peer trials
615 132nd of 2000 higher than 1,869 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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