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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03517813
Other study ID # 9745
Secondary ID RG3016008NCI-202
Status Completed
Phase
First received
Last updated
Start date January 3, 2018
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date December 31, 2022
Est. primary completion date June 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; - Women aged =18 years at the time of enrollment - Referred clinically for breast MRI for any indication Exclusion Criteria: - Known allergy or contraindication to iodinated contrast - Are currently pregnant based on urine pregnancy test - Have breast implants - Are lactating

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Contrast-enhanced Spectral Mammography (CESM)
Dual energy mammography images obtained after the administration of an intravenous contrast agent

Locations

Country Name City State
United States Seattle Cancer Care Alliance Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abnormal interpretation rate Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI) 2 years
Secondary Biopsy rate Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) 2 years
Secondary Positive predictive value for biopsy recommendation (PPV2) Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) 3 years
Secondary Negative predictive value Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) 3 years
Secondary Cancer detection rate Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) 3 years
Secondary Sensitivity Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) 2 years
Secondary Specificity Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) 2 years
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