DENSE-BAVARIA: AI-transformed dual early detection of breast cancer and diseases of the central cardiovascular system

DENSE-BAVARIA: AI-transformed dual early detection of breast cancer and diseases of the central cardiovascular system - DENSE-BAVARIA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038246

Enrollment

4000

Registered

2026-01-20

Start date

2026-01-23

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

C50.0

Interventions

Group 1: Women with (very) high breast density who have a negative mammography screening result. The women receive a native MRI investigation after the X-ray screening mammography.

Eligibility

Sex/Gender

Female

Age

50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Mammographically dense or very dense breast, negative mammography screening result

Exclusion criteria

Exclusion criteria: MRI contraindications, pregnant or lactating women, claustrophobia, adiposity (> 150 kg)

Design outcomes

Primary

Measure	Time frame
Detection rate of breast cancer in women with (very) high mammographic breast density and negative X-ray mammography findings. The detection rate is determined as follows: The breast MRI data are evaluated by radiologists with AI support in accordance with the guidelines. Any suspicious findings are further clarified using imaging techniques (ultrasound, and, if indicated, contrast-enhanced MRI). If clinically indicated by a board-vertified radiologist, and with the woman’s consent, a biopsy is performed. The detection rate is calculated as the number of detected carcinomas divided by the number of study participants.	—

Measure

Time frame

Detection rate of breast cancer in women with (very) high mammographic breast density and negative X-ray mammography findings. The detection rate is determined as follows: The breast MRI data are evaluated by radiologists with AI support in accordance with the guidelines. Any suspicious findings are further clarified using imaging techniques (ultrasound, and, if indicated, contrast-enhanced MRI). If clinically indicated by a board-vertified radiologist, and with the woman’s consent, a biopsy is performed. The detection rate is calculated as the number of detected carcinomas divided by the number of study participants.

—

Secondary

Measure	Time frame
Detection rate of previously unknown cardiovascular pathologies. Quality of life and acceptance of the measure	—

Countries

Germany

Contacts

Public ContactJudith Lach

Radiologisches Institut des Universitätsklinikums Erlangen

densebavaria.dr@uk-erlangen.de+49913148819

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026