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Microstructure modelling using enhanced diffusion-weighted magnetic resonance imaging for non-invasive prostate cancer diagnostics - a feasibility study

Microstructure modelling using enhanced diffusion-weighted magnetic resonance imaging for non-invasive prostate cancer diagnostics - a feasibility study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033122
Enrollment
300
Registered
2023-12-29
Start date
2023-12-04
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

C61

Interventions

Group 1: For men with suspected prostate cancer and an indication for an MRI, additional MRI sequences are included in the standard protocol. With the help of these new sequences, mathematical microst

Sponsors

Virdx Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients are scheduled for an mpMRI examination due to suspected prostate carcinoma

Exclusion criteria

Exclusion criteria: - patients have a contraindication for an MRI scan AND - patients have had previous radiotherapy of the prostate, hormone therapy, previous TUR-P or other prostate surgery AND - patients lack willingness, ability and capacity to consent

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity and receiver operating characteristic (ROC) curve of the different biophysical models for the diagnosis of clinically significant prostate cancer

Secondary

MeasureTime frame
Comparison with PI-RADS classification and existing biopsy results

Countries

Germany

Contacts

Public ContactAndreas Bartsch

Radiologie Bamberg

andreas.bartsch@radiologie-bamberg.de0951980300

Outcome results

None listed

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