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CESM ABMR Breast Cancer Screening Trial

NCT03517813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2023-01-06

No results posted yet for this 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).

Conditions

  • Breast Cancer Screening

Interventions

DEVICE

Contrast-enhanced Spectral Mammography (CESM)

Dual energy mammography images obtained after the administration of an intravenous contrast agent

Sponsors & Collaborators

Principal Investigators

  • Janie M Lee · Fred Hutch/University of Washington Cancer Consortium

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2021-06-22
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517813 on ClinicalTrials.gov