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Clinical Trials/DRKS00015067
DRKS00015067
Completed
Not Applicable

Clinical Evaluation of High-resolution, Contrast-enhanced Low-dose Breast-CT (Sub-study I) - Breast-CT (Sub-study I)

Klinik für Diagnostische und Interventionelle Radiologie, Uniklinik RWTH Aachen0 sites65 target enrollmentJuly 30, 2019
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ConditionsC50Malignant neoplasm of breast

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
C50
Sponsor
Klinik für Diagnostische und Interventionelle Radiologie, Uniklinik RWTH Aachen
Enrollment
65
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 30, 2019
End Date
May 7, 2021
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Klinik für Diagnostische und Interventionelle Radiologie, Uniklinik RWTH Aachen

Eligibility 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

  • •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).

Outcomes

Primary Outcomes

Not specified

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