Comparing low-dose breast CT with MRI for breast cancer diagnosis
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
This study tests whether a new low-dose breast CT scan can diagnose breast cancer just as well as the traditional MRI for women who need imaging.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 428 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AB-CT - Advanced Breast-CT GmbH Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Regensburg, Bavaria and 3 other locations) |
| Trial ID | NCT05989022 on ClinicalTrials.gov |
What this trial studies
This investigation compares the diagnostic performance of low-dose dedicated breast CT (BCT) using the nu:view system with traditional MRI for breast cancer diagnosis. The study involves a prospective non-randomized intra-individual cohort design where participants receive both imaging modalities sequentially. Patients will undergo imaging with nu:view followed by MRI within a week, with both procedures involving the use of contrast agents. The goal is to evaluate the non-inferiority of BCT compared to MRI in major diagnostic indications.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older with inconclusive findings from conventional imaging or specific indications for breast imaging.
Not a fit: Patients who are pregnant, breastfeeding, or have known genetic predispositions like BRCA mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and lower-radiation alternative for breast cancer diagnosis.
How similar studies have performed: While MRI is the gold standard for breast imaging, the use of low-dose breast CT is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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
Where this trial is running
Regensburg, Bavaria and 3 other locations
- DRZ Die Radiologen — Regensburg, Bavaria, Germany (Recruiting)
- Radiologisches Institut Universitätsklinikum Erlangen — Erlangen, Germany (Recruiting)
- Stichting Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
- Leiden University Medical Centre — Leiden, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.