NCT05458427

Dedicated Breast CT for Diagnosis of Breast Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.

Detailed description

Rationale: Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up. Objective: The primary objective of this research project is to determine the improvement in the area under the receiver operating characteristics (ROC) curve of BCT for diagnosis of breast cancer compared to that of the standard diagnostic work-up. As secondary objectives, this analysis will be performed by lesion type (microcalcifications vs. soft tissue lesions). Study design: Single arm study with each subject being its own control

Conditions

• Breast Cancer

Timeline

• Start date: 2016-10-21
• Primary completion: 2024-01-09
• Completion: 2024-01-09
• First posted: 2022-07-14
• Last updated: 2024-02-26

Locations

2 sites across 1 country: Netherlands