NCT05404087

Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer

Clinical Evaluation of Contrast Enhanced Breast CT to Improve Staging and Treatment Follow up in Women With Breast Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 413 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Contrast-enhanced breast CT is a novel high resolution and fully 3D imaging method to document abnormalities within the breast. I will establish its value for breast cancer staging and in monitoring therapy response.

Detailed description

Breast CT is a novel modality that has not been largely evaluated in a clinical setting. Only recently FDA and CE marked BCT machines have been released, and the number of installed bases internationally is below 10 (although rapidly rising). Internationally only a few studies on contrast enhanced breast CT have been performed in small numbers of patients, albeit with excellent results. Nevertheless, substantial evidence for this novel modality is still absent. In particular, the correlation of enhancement and histological grade of DCIS, correlation of CEBCT findings with histopathology, and prediction and assessment of primary systemic treatment are open fields for which more substantial evaluation is clearly needed. In this study we want to establish the value of CEBCT in staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS), and in the evaluation of women treated with primary systemic therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Dedicated breast CT	Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2022-06-03
• Last updated: 2022-06-03

Regulatory

• FDA-regulated device study