Clinical trial · Interventional
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
NCT05989022CI-TRIAL-00110755completedN/AClinicalTrials.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)
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
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 Diagnosis | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of contrast enhancing agent Gadovist for MRI investigation | Diagnostic Test | — | UNRESOLVED |
| Injection of contrast enhancing agent Imeron for B-CT investigation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Imaging Breast Diagnostic
- description
- Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient
- interventionNames
- Diagnostic Test: Injection of contrast enhancing agent Gadovist for MRI investigation
- Diagnostic Test: Injection of contrast enhancing agent Imeron for B-CT investigation
Primary outcomes (1)
- measure
- Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
- timeFrame
- one year
- description
- The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis. Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sex: female 2. Age: at least 18 years 3. Inconclusive findings in conventional imaging or preoperative staging or evaluation of therapy response in the neoadjuvant chemotherapy setting or imaging of the breast after breast-conserving therapy or finding the cause of hemorrhagic nipple discharge or prosthesis imaging or screening of women with hereditary or familial increased risk for the development of breast cancer or axillary lymph node metastasis suspected to originate from breast tissue 4. Persons able and willing to understand and sign informed consent form Exclusion Criteria: 1. Known pregnancy or breastfeeding 2. Presence of BRCA1 or BRCA2 allele 3. Insufficient renal function (MDRD) 4. Dysfunction of the thyroid gland (TSH degradation) 5. Known allergy or intolerance against iodine-containing contrast enhancing agents or MRI contrast enhancing agents 6. Patients with paramagnetic or magnetic material inside the breast, claustrophobia
References
Publications (0)
Data not yet available
No reference posted for this study.