Feasibility of 3D Breast Ultrasound in comparison with 3D breast MRI Amendement: Analysis of false positive rate with 3D ultrasound

Feasibility of 3D Breast Ultrasound in comparison with 3D breast MRI Amendement: Analysis of false positive rate with 3D ultrasound - 3D Breast Ultrasound in comparison with 3D breast MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36527

Enrollment

200

Registered

2010-10-07

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Breast neoplasmata

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients who are scheduled for MRI of the breast in accordance of current practice in the Jeroen Bosch Hospital will be invited to participate. Inclusion period will be approximatly 3 months. Amendement: Additionally patients will be included who are scheduled for a routine mammography

Exclusion criteria

Exclusion criteria: 1.Patients who are unable to provide informed consent; 2.Patients who cannot undergo adequate examination with breast ultrasound and MRI or who are unable to cooperate; 3.Patients who, for logistic reasons, cannot be examined by ABVS within a period of one week prior or after MRI.

Design outcomes

Primary

Measure	Time frame
Study parameters -Study parameters are the difference in detection performance, reproducibility and inter-observer agreement of ABVS compared to MRI and hand-held US. -Detection performance is measured by detection rate, sensitivity, specificity, positive and negative predictive values, and area under the ROC based on BIRADS scores. Amnedement: analysis of the false positive rate.	—

Secondary

Measure	Time frame
n.a. (see primairy study parameters)	—

Countries

Netherlands

Outcome results