Clinical trial · Observational
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
NCT05404087CI-TRIAL-00058889CEBCTvsMRIunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dedicated breast CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pre-operative staging of breast cancer with CEBCT
- description
- Women who have been diagnosed with breast cancer and need to have a pre-operative staging and this will be done with contrast-enhanced breast CT.
- interventionNames
- Device: Dedicated breast CT
- label
- Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy
- description
- Women who are selected for neo-adjuvant chemotherapy to reduce the size of the tumor need to be followed-up in order to evaluate the treatment response.
- interventionNames
- Device: Dedicated breast CT
Primary outcomes (2)
- measure
- Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnoses of breast cancer * Scheduled for a pre-surgery staging contrast enhanced breast MRI * Eligible for primary systemic therapy Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.