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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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