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NCT03517813 · ClinicalTrials.gov registry record
CESM ABMR Breast Cancer Screening Trial
A clinical trial, sponsored by University of Washington.
- Completed
- Registry status
- 256
- Enrollment target
NCT03517813: Completed study, sponsored by University of Washington.
NCT03517813 is a clinical trial that has completed, run by University of Washington. The registered enrollment target is 256 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03517813 has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- 256 participants
- Enrollment target
Study Summary
This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy. Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3). Secondary Aims: 1. Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities. 2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).
Primary Outcome
Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Interventions
- DEVICE Contrast-enhanced Spectral Mammography (CESM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2022-12-31 |
What the finished NCT03517813 record still lists
NCT03517813 is an observational study that tracks outcomes without assigning an intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Contrast-enhanced Spectral Mammography (CESM) is the first listed.
NCT03517813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03517813 about?
NCT03517813 is a clinical study titled "CESM ABMR Breast Cancer Screening Trial". This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy. Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard bre...
What is the current status of trial NCT03517813?
This trial is currently completed. The enrollment target is 256 participants. The study started on 2018-01-03. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03517813?
The interventions under investigation include: Contrast-enhanced Spectral Mammography (CESM) (DEVICE).
Who is sponsoring clinical trial NCT03517813?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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