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NCT03954015 · ClinicalTrials.gov registry record · Early Phase 1
Comparison of Three Methods for Early Detection of Breast Cancer
A Early Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT03954015: Completed Early Phase 1 study, sponsored by Mayo Clinic.
NCT03954015 is a Early Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03954015, a Early Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).
Primary Outcome
The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
Interventions
- DRUG Lumason
- DIAGNOSTIC_TEST Contrast Enhanced imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2021-10-05 |
| Phase | Early Phase 1 |
What the finished NCT03954015 record still lists
NCT03954015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Lumason is the first listed.
NCT03954015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03954015 about?
NCT03954015 is a clinical study titled "Comparison of Three Methods for Early Detection of Breast Cancer". Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).
What is the current status of trial NCT03954015?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2019-10-15. Estimated completion is 2021-10-05.
What interventions are being tested in trial NCT03954015?
The interventions under investigation include: Lumason (DRUG), Contrast Enhanced imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03954015?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03954015's enrollment target sits among peer trials
3 1949th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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