CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
Recruiting
Phase 4
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 30 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 2,100 (estimated)
- Sponsor
- Margarita Louise Zuley · Other
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About This Trial
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 d…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject is female of any race and ethnicity
* Subject is ≥30 years old
* Subject is diagnosed with a suspicious breast abnormality and is scheduled for an imaging directed breast biopsy.
Exclusion Criteria:
* Subject is unable or unwilling to undergo informed consent
* Subje…
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