NL-OMON56808Not yet recruitingNot Applicable
Comparison of low-dose spiral breast CT with MRI in major indications of MRI for breast diagnostics - ldBCT-MRI-C
AB-CT-Advanced Breast-CT GmbH0 sites300 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 prosthesis imaging or
- •screening of women with hereditary or finding the cause of hemorrhagic nipple
- •discharge 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 and other exclusion criteria for MRI
Investigators
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