Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a clinical trial that has completed, run by University of Washington. The registered enrollment target is 256 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03517813
The ClinicalTrials.gov registry entry for NCT03517813 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Contrast-enhanced Spectral Mammography (CESM) is the first listed.
NCT03517813 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.