Status:
RECRUITING
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
Lead Sponsor:
AB-CT - Advanced Breast-CT GmbH
Collaborating Sponsors:
CRO Dr. med Kottmann GmbH & Co. KG
RQM+
Conditions:
Breast Cancer Diagnosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
Detailed Description
The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, develope...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT05989022
Start Date
November 24 2023
End Date
December 1 2025
Last Update
January 30 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
DRZ Die Radiologen
Regensburg, Bavaria, Germany, 93059
2
Radiologisches Institut Universitätsklinikum Erlangen
Erlangen, Germany, 91054
3
Stichting Martini Ziekenhuis
Groningen, Netherlands, 9728 NT
4
Leiden University Medical Centre
Leiden, Netherlands, 2333 ZA