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Imaging and molecular detection of markers for disease risk prediction, improvement of diagnostic accuracy, and prognosis of patients with breast changes – A combined case-control and cohort study

Imaging and molecular detection of markers for disease risk prediction, improvement of diagnostic accuracy, and prognosis of patients with breast changes – A combined case-control and cohort study - iMODE-B Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038001
Enrollment
1548
Registered
2025-10-01
Start date
2011-10-06
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50-C50

Interventions

Group 1: Women who enter this study will be diagnosed either as breast cancer cases or controls without breast cancer. The definitions are as follows: Cases are patients, who have a histologically con

Sponsors

Frauenklinik des Uniklinikums Erlangen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Signed informed consent. 2) Indication for a routine mammogram and ultrasound (indication for this examination is not allowed to be made within the study. The examination must be part of routine examinations for diagnostic purposes).

Exclusion criteria

Exclusion criteria: 1) Previous diagnosis of breast cancer or precursor lesions such as DCIS or atypical ductal or lobular hyperplasia 2) Indication for a mammogram or an ultrasound which is not a routine examination 3) Indication for a mammogram as part of a follow up examination for a previous BIRADS 3 assessment of any imaging method 4) Unknown reason for the presentation or the referral of the patient.

Design outcomes

Primary

MeasureTime frame
We intend to investigate the diagnostic accuracy of several imaging techniques, which are used in clinical routine (mobile ultrasound, routine mammography and routine ultrasound with conventional ultrasound machines). The primary study aim is the improvement of the diagnostic accuracy of routine mammography and the identification of risk factors for breast cancer at the timepoint of primary diagnosis.

Secondary

MeasureTime frame
Several secondary study aims (SSA) will be pursued within this study and are concerned mainly with the correlation of imaging, tumor and patient characteristics with the diagnostic accuracy either for breast cancer in general, for specific subtypes of breast cancer or metastasis.

Countries

Germany

Contacts

Public ContactPeter A. Fasching

Frauenklinik des Uniklinikums Erlangen

Peter.Fasching@uk-erlangen.de+49 9131 85 33553

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026