CompletedNot Applicable

Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics

Germany, Netherlands293 participantsStarted 2023-11-24

Plain-language summary

Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis

Timeframe: one year

Trial details

NCT IDNCT05989022

SponsorAB-CT - Advanced Breast-CT GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-24

View on ClinicalTrials.gov More Breast Cancer Diagnosis trials