NCT05989022

Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: AB-CT - Advanced Breast-CT GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems

Detailed description

The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging. The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics. The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.

Conditions

• Breast Cancer Diagnosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Injection of contrast enhancing agent Gadovist for MRI investigation	Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
DIAGNOSTIC_TEST	Injection of contrast enhancing agent Imeron for B-CT investigation	Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis

Timeline

• Start date: 2023-11-24
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-08-14
• Last updated: 2025-01-30

Locations

4 sites across 2 countries: Germany, Netherlands