Breast Cancer DiagnosisNCT05989022
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
A study testing Injection of contrast enhancing agent Gadovist for MRI investigation and Injection of contrast enhancing agent Imeron for B-CT investigation in people with Breast Cancer Diagnosis, run by AB-CT - Advanced Breast-CT GmbH at 4 sites in 2 countries.
Trial summary
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Diagnosis
- What is being tested?
- Injection of contrast enhancing agent Gadovist for MRI investigation and Injection of contrast enhancing agent Imeron for B-CT investigation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Nov 2023to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Radiologisches Institut Universitätsklinikum Erlangen
Erlangen, 91054
DRZ Die Radiologen
Regensburg, Bavaria, 93059
Netherlands2 sites
Stichting Martini Ziekenhuis
Groningen, 9728 NT
Leiden University Medical Centre
Leiden, 2333 ZA
About this study
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
Read the detailed description
The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging.
The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.
The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.
- Conditions
- Breast Cancer Diagnosis
- Being tested
- Injection of contrast enhancing agent Gadovist for MRI investigation, Injection of contrast enhancing agent Imeron for B-CT investigation
- Keywords
- Breast CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of contrast enhancing agent Gadovist for MRI investigationDiagnostic test
Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
Injection of contrast enhancing agent Imeron for B-CT investigationDiagnostic test
Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Imaging Breast Diagnostic | Other | Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient Receives: Diagnostic Test: Injection of contrast enhancing agent Gadovist for MRI investigation; Diagnostic Test: Injection of contrast enhancing agent Imeron for B-CT investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis.
Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.
Measured: one year
Secondary outcomes (1)
Collect data for comfort of CE-BCT and CE-MRI
The secondary objective is to collect data for comfort of CE-BCT and CE-MRI using a patient questionnaire of closed questions. The questionnaire asks in 7 categories for 1. Overall rating of the examination 2. Comfort of the device during examination 3. The feel of the operating noise of the device 4. The rating of the space provided by the device 5. The duration of the examination 6. The question if the patient would agree to have the examination again, if necessary with the device 7. After both modalities which diagnostic method would be the preference, MRI or BCT. Every question can be rated with 5 possible ratings from very good to very bad or adapted possibilities like pleasantly quit to unpleasantly loud.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start24 Nov 2023
- Primary completion24 Nov 2025
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison between both modalities in single patients
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB-CT - Advanced Breast-CT GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRO Dr. med Kottmann GmbH & Co. KG, RQM+
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989022
- Sponsor's protocol ID
- ldBCT-MRI-C
- Status last verified
- May 2026
- First submitted
- 25 Jul 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
- ClinicalTrials.gov ID
- NCT05989022
- Acronym / sponsor ID
- ldBCT-MRI-C
- Conditions
- Breast Cancer Diagnosis
- Keywords
- Breast CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- AB-CT - Advanced Breast-CT GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CRO Dr. med Kottmann GmbH & Co. KG, RQM+
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
Detailed description
The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging.
The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.
The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison between both modalities in single patients
| Arm | Type | Receives |
|---|---|---|
| Imaging Breast Diagnostic | Other | Diagnostic Test: Injection of contrast enhancing agent Gadovist for MRI investigation, Diagnostic Test: Injection of contrast enhancing agent Imeron for B-CT investigationImaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of contrast enhancing agent Gadovist for MRI investigationImage enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis | Diagnostic test | Imaging Breast Diagnostic |
| Injection of contrast enhancing agent Imeron for B-CT investigationImage enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis | Diagnostic test | Imaging Breast Diagnostic |
Primary outcome
Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
Time frame: one year
The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis. Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.
1 secondary outcome
Collect data for comfort of CE-BCT and CE-MRI
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of contrast enhancing agent Gadovist for MRI investigation and Injection of contrast enhancing agent Imeron for B-CT investigation in people with Breast Cancer Diagnosis, run by AB-CT - Advanced Breast-CT GmbH at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.