C50
Conditions
Interventions
Group 1: Sub-projekt A:
Women with known breast cancer (proved by core biopsy, categorized as BI-RADS 6) and women with a high likelihood of having breast cancer based on conventional Imaging findings
Sponsors
Klinik für Diagnostische und Interventionelle Radiologie, Uniklinik RWTH Aachen
Eligibility
Sex/Gender
Female
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Sub-project A (Finished): 1) Women in either BI-RADS 6 situation (i.e. already biopsy proven breast cancer), or women who, based on conventional Imaging, exhibit a lesion categorized as BIRADS-5 (i.e. a high likelihood of breast cancer) (tested value not older than 8 weeks). 2) Women with normal renal function (MDRD with GFR >= 60 ml/min/1,73m2). 3) Women with normal thyroid function as evidenced by a clinically unobstrusive TSH value. 4) Women who are able to provide informed written consent and are aware of the nature, meaning and extent of the study. 3) Women who provided this written informed consent. Sub-project B: 1) Same as for sub-project A. 2) Women with non-malignant lesions as defined as being categorized as BI-RADS 4 by conventional imaging-findings.
Exclusion criteria
Exclusion criteria: For sub-project A+B: 1) Women not fulfilling the inclusion criteria. 2) Pregnant or breastfeeding women. 3) Women in child-bearing age without sufficient contraception. 4) Women less than 40 years of age. 5) Women with a body weight larger than 135 kg. 6) Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or risk of BRCA1-heterozygosity >= 25%. 7) Terminal or advanced renal insufficiency (GFR < 60 ml/min/1,73 m2). 8) Clinical or laboratory signs of an endocrine autonomy (TSH suppression). 9) Known allergies or intolerances grade II or higher for iodinated contrast agents (Iopromide). 10) Hospitalization was ordered by court or local authorities. 11) Relationship of dependence or employment to sponsor or investigator. 12) Simultaneous participation in another clinical trial. 13) Being unwilling to follow the instructions of the investigator. 14) Women who lack the mental ability or capacity to understand the explanations and the nature of the study as well as its meaning, aims and focus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub-project A: Suitable image acquisition protocols for unenhanced and enhanced and dynamic contrast breast CT. Sub-project B: Appropriate diagnostic criteria for differential diagnosis of benign and malignant, invasive and pre-invasive breast lesions in unenhanced and contrast-enhanced, and in dynamic contrast-enhanced breast CT imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sub-projects I + II: Investigation of enhancement kinetics of benign vs. malignant lesions in dynamic contrast enhanced breast CT. | — |
Countries
Germany
Contacts
Public ContactChristiane Kuhl
Klinik für Diagnostische und Interventionelle Radiologie, Uniklinik RWTH Aachen
Outcome results
None listed