Diagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies

Diagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies - Diagnostic value of three-dimensional breast ultrasound

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47752

Enrollment

600

Registered

2017-11-07

Start date

2018-04-05

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer breast neoplasm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants of Dutch breast cancer screening with a BI-RADS 0 mammography result, who are referred to one of the participating hospitals for further diagnostic work-up.

Exclusion criteria

Exclusion criteria: Inability to understand study information

Design outcomes

Primary

Measure	Time frame
The primary outcome is the accuracy of different imaging strategies in diagnosing breast cancer, expressed as the area under the receiver operating characteristic (ROC) curve. Pathology or the results of all imaging modalities are used as the reference standard. All study participants will be followed up to the next scheduled screening round approximately 2 years later to determine if any breast cancer was missed. The imaging modalities under study, supplemental to the full-field digital screening mammography, are 3DUS, digital breast tomosynthesis (DBT) and handheld ultrasound (HHUS).	—

Measure

Time frame

The primary outcome is the accuracy of different imaging strategies in diagnosing breast cancer, expressed as the area under the receiver operating characteristic (ROC) curve. Pathology or the results of all imaging modalities are used as the reference standard. All study participants will be followed up to the next scheduled screening round approximately 2 years later to determine if any breast cancer was missed. The imaging modalities under study, supplemental to the full-field digital screening mammography, are 3DUS, digital breast tomosynthesis (DBT) and handheld ultrasound (HHUS).

—

Secondary

Measure	Time frame
The diagnostic accuracy of the different imaging strategies among subgroups of patients based on mammographic density and age. The biopsy referral rate for the different imaging strategies under study. The interobserver reliability for 3DUS.	—

Countries

Netherlands

Outcome results