Prostate MRI: Steam DWI, T1 Mapping and 3D Sequences

Prostate MRI: Steam DWI, T1 Mapping and 3D Sequences - N/A

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00018062

Enrollment

400

Registered

2019-08-23

Start date

2020-11-25

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C61 N40

Interventions

Group 1: Single arm study: assessment of the clinical implementation of new prostate MRI sequences without need for additional i.v. contrast media administration.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients presenting for prostate MRI

Exclusion criteria

Exclusion criteria: MRI contraindications; patients post prostatectomy

Design outcomes

Primary

Measure	Time frame
The primary aim of our study is to correctly detect and assess prostate lesions as benign or malignant using the PIRADS 2 system. Histopathological assessments or imaging follow-ups will be used as gold standard. The diagnostic accuracy of novel MRI sequences will be assessed using 2x2 tables, sensitivity/specificity and 95% confidence intervals. One patient will be used to define one observation. Novel MRI sequence diagnostic accuracy will be compared to standard MRI sequences using the McNemar test. Potentially, radiomics analyses and machine learning algorithms will be implemented for further assessment of diagnostic accuracy. For all statistical analyses, an alpha level of 0.05 will be considered statistically significant. Following the study amendment in January 2022, the diagnostic accuracy of blood biomarkers to detect and classify prostate cancer and its histological grades will be assessed using ROC-curves and AUC.	—

Measure

Time frame

The primary aim of our study is to correctly detect and assess prostate lesions as benign or malignant using the PIRADS 2 system. Histopathological assessments or imaging follow-ups will be used as gold standard. The diagnostic accuracy of novel MRI sequences will be assessed using 2x2 tables, sensitivity/specificity and 95% confidence intervals. One patient will be used to define one observation. Novel MRI sequence diagnostic accuracy will be compared to standard MRI sequences using the McNemar test. Potentially, radiomics analyses and machine learning algorithms will be implemented for further assessment of diagnostic accuracy. For all statistical analyses, an alpha level of 0.05 will be considered statistically significant. Following the study amendment in January 2022, the diagnostic accuracy of blood biomarkers to detect and classify prostate cancer and its histological grades will be assessed using ROC-curves and AUC.

—

Secondary

Measure	Time frame
Prevalence and degree of imaging artefacts will be descriptively analysed and compared between novel and standard MRI sequences using chi2-tests. 2x2 tables will be used for assessment of benign changes on T1 maps. Correct anatomical correlation with 3D sequences will be descriptively evaluated, including location and spatial disagreement compared to prostate biopsy and prostatectomy.	—

Countries

Germany

Contacts

Public ContactJohannes Uhlig

Department of Diagnostic and Interventional Radiology, University Medical Center Goettingen

johannes.uhlig@med.uni-goettingen.de0049 551 39 68965

Outcome results

None listed

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