Breast CancerNCT07881679
Breast MRI for Early Detection of Breast Cancer in Thuringia
An observational study of Breast Cancer, run by Jena University Hospital at 1 site in Germany.
Trial summary
Breast magnetic resonance imaging (MRI) has different diagnostic characteristics from conventional mammography and may detect breast cancers that are difficult to identify using mammography. 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
- What is being tested?
- Breast MRI
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Women who participated in the original Thuringian breast MRI early detection study, in which breast MRI was used as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. All eligible participants from the original MRI early detection cohort will be considered for inclusion in the present retrospective diagnostic accuracy analysis. Diagnostic performance will be assessed using MRI findings, subsequent diagnostic assessment and histopathology, and longitudinal cancer ascertainment including population-based cancer registry data.
Who may be able to join
- Breast MRI performed as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography.
- Evaluable breast MRI examination.
- Adequate reference-standard information to determine breast cancer status.
- A mammogram or ultrasound could not clearly show whether breast cancer has returned. This may be after breast-conserving treatment (surgery and/or radiotherapy) or after breast reconstruction.
- A follow-up breast examination should be carried out every 2 years after the operation.
- There is a familial risk, for example because first-degree relatives already have or have had breast cancer.
- The mammogram cannot be interpreted because of dense breast tissue.
Who cannot join
- MRI early detection examination not completed or technically non-evaluable.
- Insufficient data to determine the MRI assessment.
- Not a resident of Thuringia
- Bilateral mastectomies
- BIRADS 6
- Missing follow-up
- Examination discontinued
Trial locations and contacts
1 site in 1 country.
Germany1 site
Jena University Hospital, Department of Radiology
Jena, Thuringia, 07747
About this study
Official title: Diagnostic Accuracy of Breast MRI as the Primary Modality for Early Detection of Breast Cancer in Thuringia: A Retrospective Registry-Linked Study
Breast magnetic resonance imaging (MRI) has different diagnostic characteristics from conventional mammography and may detect breast cancers that are difficult to identify using mammography. In a predefined study population in Thuringia, Germany, breast MRI was performed as the primary imaging examination for early detection of breast cancer instead of conventional mammography.
The primary purpose of this study is to assess the quality and performance of the MRI-based breast cancer early detection program. This retrospective diagnostic accuracy study will evaluate the performance of breast MRI using MRI data collected for early breast cancer detection, subsequent diagnostic assessment and histopathological data, and longitudinal population-based cancer registry information.
The primary objective is to determine the sensitivity of breast MRI for detection of invasive breast cancer. Specificity, program sensitivity, interval breast cancer, predictive values, receiver operating characteristic measures, cancer detection and interval cancer rates, diagnostic assessment and biopsy rates, ductal carcinoma in situ, and tumor characteristics will be evaluated as secondary outcomes.
- Conditions
- Breast Cancer
- Being tested
- Breast MRI
- Keywords
- Breast magnetic resonance imaging, Diagnostic accuracy, Interval breast cancer, Breast cancer early detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIDiagnostic test
Contrast-enhanced breast magnetic resonance imaging performed as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. MRI examinations were interpreted according to the assessment criteria specified in the original study protocol. Detailed MRI acquisition and interpretation parameters, including MRI system, field strength, breast coil, imaging sequences, contrast agent, reader characteristics, and assessment categories, will be retrieved from the original study documentation.
| Study group | Role | What they receive |
|---|---|---|
| Breast MRI Early Detection Cohort | Women who participated in the original Thuringian breast cancer early detection study and underwent breast MRI as the protocol-defined primary examination for early detection of breast cancer instead of conventional mammography. Diagnostic performance will be evaluated retrospectively using MRI findings, subsequent diagnostic assessment and histopathology, and longitudinal cancer ascertainment. Receives: Diagnostic Test: Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Breast MRI for Invasive Breast Cancer
Sensitivity will be calculated as the proportion of participants with invasive breast cancer who had a positive index MRI examination:
Sensitivity = true positives / (true positives + false negatives). Invasive breast cancer status will be determined using histopathological verification and longitudinal cancer ascertainment according to the prespecified composite reference standard. Sensitivity will be reported with a two-sided 95% confidence interval.
Measured: Index MRI examination through 24 months after the index examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Jan 2018
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Landeskrebsregister Thüringen, Techniker Krankenkasse
- Responsible party
- Sponsor
- Investigators
- Ulf Prof. Teichgräber, MD, Study director, Friedrich-Schiller-University Jena, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881679
- Sponsor's protocol ID
- MRI Breast Cancer Thuringia
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2026
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Breast MRI as the Primary Modality for Early Detection of Breast Cancer in Thuringia: A Retrospective Registry-Linked Study
- ClinicalTrials.gov ID
- NCT07881679
- Acronym / sponsor ID
- MRI Breast Cancer Thuringia
- Conditions
- Breast Cancer
- Keywords
- Breast magnetic resonance imaging, Diagnostic accuracy, Interval breast cancer, Breast cancer early detection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Landeskrebsregister Thüringen, Techniker Krankenkasse
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 19 Oct 2026 (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.
Breast magnetic resonance imaging (MRI) has different diagnostic characteristics from conventional mammography and may detect breast cancers that are difficult to identify using mammography. In a predefined study population in Thuringia, Germany, breast MRI was performed as the primary imaging examination for early detection of breast cancer instead of conventional mammography.
The primary purpose of this study is to assess the quality and performance of the MRI-based breast cancer early detection program. This retrospective diagnostic accuracy study will evaluate the performance of breast MRI using MRI data collected for early breast cancer detection, subsequent diagnostic assessment and histopathological data, and longitudinal population-based cancer registry information.
The primary objective is to determine the sensitivity of breast MRI for detection of invasive breast cancer. Specificity, program sensitivity, interval breast cancer, predictive values, receiver operating characteristic measures, cancer detection and interval cancer rates, diagnostic assessment and biopsy rates, ductal carcinoma in situ, and tumor characteristics will be evaluated as secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast MRI Early Detection Cohort | – | Diagnostic Test: Breast MRIWomen who participated in the original Thuringian breast cancer early detection study and underwent breast MRI as the protocol-defined primary examination for early detection of breast cancer instead of conventional mammography. Diagnostic performance will be evaluated retrospectively using MRI findings, subsequent diagnostic assessment and histopathology, and longitudinal cancer ascertainment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who participated in the original Thuringian breast MRI early detection study, in which breast MRI was used as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. All eligible participants from the original MRI early detection cohort will be considered for inclusion in the present retrospective diagnostic accuracy analysis. Diagnostic performance will be assessed using MRI findings, subsequent diagnostic assessment and histopathology, and longitudinal cancer ascertainment including population-based cancer registry data.
Key inclusion criteria (7 listed)
- Breast MRI performed as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography.
- Evaluable breast MRI examination.
- Adequate reference-standard information to determine breast cancer status.
- A mammogram or ultrasound could not clearly show whether breast cancer has returned. This may be after breast-conserving treatment (surgery and/or radiotherapy) or after breast reconstruction.
- A follow-up breast examination should be carried out every 2 years after the operation.
Key exclusion criteria (7 listed)
- MRI early detection examination not completed or technically non-evaluable.
- Insufficient data to determine the MRI assessment.
- Not a resident of Thuringia
- Bilateral mastectomies
- BIRADS 6
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 |
|---|---|---|
| Breast MRIContrast-enhanced breast magnetic resonance imaging performed as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. MRI examinations were interpreted according to the assessment criteria specified in the original study protocol. Detailed MRI acquisition and interpretation parameters, including MRI system, field strength, breast coil, imaging sequences, contrast agent, reader characteristics, and assessment categories, will be retrieved from the original study documentation. | Diagnostic test | Breast MRI Early Detection Cohort |
Primary outcome
Sensitivity of Breast MRI for Invasive Breast Cancer
Time frame: Index MRI examination through 24 months after the index examination
Sensitivity will be calculated as the proportion of participants with invasive breast cancer who had a positive index MRI examination: Sensitivity = true positives / (true positives + false negatives). Invasive breast cancer status will be determined using histopathological verification and longitudinal cancer ascertainment according to the prespecified composite reference standard. Sensitivity will be reported with a two-sided 95% confidence interval.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
Ulf Prof. Teichgräber, MD study director
Friedrich-Schiller-University Jena, Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Jena University Hospital at 1 site in Germany.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity of Breast MRI for Invasive Breast Cancer (time frame: Index MRI examination through 24 months after the index examination). 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 19 Oct 2026.