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NCT05206331 · ClinicalTrials.gov registry record · Phase 4
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
A Phase 4 study of Breast Cancer, sponsored by Margarita Louise Zuley.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 2,100
- Enrollment target
- 1
- Study location
NCT05206331: Recruiting Phase 4 study of Breast Cancer, sponsored by Margarita Louise Zuley.
NCT05206331 is a Phase 4 study of Breast Cancer that is actively recruiting participants, run by Margarita Louise Zuley. The registered enrollment target is 2,100 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206331, a Phase 4 study of Breast Cancer, is actively recruiting participants, sponsored by Margarita Louise Zuley.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 2,100 participants
- Enrollment target
- 1
- Study location
Study Summary
One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving very high cancer detection. The investigators propose a prospective clinical study of patients with diagnostic mammograms rated as BIRADS 4A or 4B and scheduled for a biopsy, in which, prior to undergoing their scheduled biopsy, a CEM procedure is performed. The investigators will test the primary hypothesis that for soft tissue lesions (i.e. masses, asymmetries, architectural distortions) initially rated BI-RADS 4A/4B adding CEM will reduce, by at least 20%, the number of biopsy recommendations for actually benign cases and, at the same time, provide a negative predictive value (NPV) higher than 95%.
Primary Outcome
The investigators will estimate and compare the changes in NPV of pre- and post CEM-based recommendations (where NPV is the proportion of pathology verified benign lesions out of post-CEM-downgraded to BIRADS 3 or lower).
Conditions Studied
Interventions
- DEVICE contrast enhanced mammography
- DRUG Iodinated Contrast Media (ICM)
Study Locations (1)
Pennsylvania
- UPMC Magee-Womens Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,100 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 4 |
What NCT05206331 shows while recruiting
NCT05206331 is an interventional study that assigns participants to a tested intervention. Its 2,100 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which contrast enhanced mammography is the first listed.
NCT05206331 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05206331 about?
NCT05206331 is a clinical study titled "CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study". One of the primary criticisms of mammography is that it leads to unneeded stress and anxiety from identification and biopsy of non-cancerous findings. Contrast-enhanced mammography (CEM) has the potential to significantly reduce biopsy rates for commonly seen benign breast lesions while preserving v...
What is the current status of trial NCT05206331?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 2,100 participants. The study started on 2022-02-01. Estimated completion is 2027-11-30.
What conditions does trial NCT05206331 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05206331?
The interventions under investigation include: contrast enhanced mammography (DEVICE), Iodinated Contrast Media (ICM) (DRUG).
Who is sponsoring clinical trial NCT05206331?
This trial is sponsored by Margarita Louise Zuley, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05206331 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05206331's enrollment target sits among peer trials
2,100 67th of 1224 higher than 1,158 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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