RecruitingNot ApplicableNCT05989022
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
Sponsor
AB-CT - Advanced Breast-CT GmbH
Enrollment
428 participants
Start Date
Nov 24, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- Sex: female
- Age: at least 18 years
- 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
- Persons able and willing to understand and sign informed consent form
Exclusion Criteria6
- Known pregnancy or breastfeeding
- Presence of BRCA1 or BRCA2 allele
- Insufficient renal function (MDRD)
- Dysfunction of the thyroid gland (TSH degradation)
- Known allergy or intolerance against iodine-containing contrast enhancing agents or MRI contrast enhancing agents
- Patients with paramagnetic or magnetic material inside the breast, claustrophobia
Interventions
DIAGNOSTIC_TESTInjection of contrast enhancing agent Imeron for B-CT investigation
Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
DIAGNOSTIC_TESTInjection of contrast enhancing agent Gadovist for MRI investigation
Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05989022