New breast CT scan could rival MRI for cancer detection
NCT ID NCT05989022
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a low-dose contrast-enhanced breast CT (CE-BCT) can match the accuracy of contrast-enhanced MRI (CE-MRI) for diagnosing breast cancer. 293 women with various breast concerns received both scans, and three independent experts rated the images. The goal was to see if CE-BCT is non-inferior to CE-MRI in detecting lesions. Patient comfort was also measured through questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- contrast agents (Gadovist for MRI, Imeron for breast CT)
- What this could lead to
- If successful, this could offer a faster, more comfortable alternative to MRI for breast cancer diagnosis, potentially reducing scan time and patient anxiety.
- What could go wrong
- This is a completed study comparing imaging methods, not a treatment trial. Even if breast CT matches MRI accuracy, it may not replace MRI for all cases, and radiation exposure from CT is a consideration.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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293 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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DRZ Die Radiologen
Regensburg, Bavaria, 93059, Germany
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Leiden University Medical Centre
Leiden, 2333 ZA, Netherlands
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Radiologisches Institut Universitätsklinikum Erlangen
Erlangen, 91054, Germany
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Stichting Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
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