NCT02798562

Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Even though the implementation of the digital mammography combined with the mandatory screening-programs lead to significant improvements, sensitivity and specificity of these examinations need to be clearly classified as improvable. Generally, it is stated that the necessary transit from 2-D projected images to 3-D tomography will be crucially advantageous as magnetic resonance imaging has already shown. Similar or even major advantages can be expected by new approaches regarding CT with very high local resolution, better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening. A device that meets these demands and is also applicable for dynamic scans after intravenous administration of a contrast agent, has been developed with the support by the European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF). Publications on technical and experimental results are already available. An evaluation in the clinical use is missing yet. The primary aim of this study is to evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of the breast.

Conditions

• BI-RADS 4
• BI-RADS 5
• BI-RADS 6
• High Risk of Breast Cancer Which Indicates a Mamma-MRI

Interventions

Type	Name	Description
DEVICE	Native and dynamic contrast-enhanced CT

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-06-14
• Last updated: 2016-06-16