Status:
UNKNOWN
Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
The Netherlands Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 t...
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 internationa...
Eligibility Criteria
Inclusion
- Diagnoses of breast cancer
- Scheduled for a pre-surgery staging contrast enhanced breast MRI
- Eligible for primary systemic therapy
Exclusion
- Women with suspected or confirmed pregnancy
- Women with prior history of breast cancer
- Women who are breastfeeding
- Women who are very frail and unable to cooperate
- Women who cannot give informed consent
- Contra indication of iodine contrast (i.e. untreatable contrast allergy, renal function impairment (GFR \<60 ml/min/1.73m2))
- Contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer)
- Male subjects
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT05404087
Start Date
August 1 2022
End Date
August 1 2025
Last Update
June 3 2022
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