Deep Learning Super Resolution Reconstruction for Fast and Motion Robust T2-weighted Prostate MRI
1 other identifier
interventional
109
1 country
1
Brief Summary
The aim of this study was therefore to investigate a new unrolled DL super resolution reconstruction of an initially low-resolution Cartesian T2 turbo spin echo sequence (T2 TSE) and compare it qualitatively and quantitatively to standard high-resolution Cartesian and non-Cartesian T2 TSE sequences in the setting of prostate mpMRI with particular interest in image sharpness, conspicuity of lesions and acquisition time. Furthermore, the investigators assessed the agreement of assigned PI-RADS scores between deep learning super resolution and standard sequences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Aug 2022
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFirst Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedApril 19, 2023
April 1, 2023
4 months
February 6, 2023
April 6, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Qualitative assessment of image quality (Artifacts, image sharpness, lesion conspicuity, capsule delineation, overall image quality and diagnostic confidence)
Artifacts, image sharpness, lesion conspicuity, capsule delineation, overall image quality and diagnostic confidence were rated on a 5-point-Likert-Scale with 1 being non-diagnostic and 5 being excellent. Friedman test was used for significance testing with p\<0.05 considered as indicative of a significant difference.
4 months
Acquisition time
Measurement of acquisition time of T2-weighted sequences
4 months
Degree of agreement on PI-RADS ratings
To assess the PI-RADS score, all MRIs were read blinded by a radiologist with 11 years expertise at two different time points in random order. The MRI sequences for PI-RADS assessment included either T2NC (reference standard at our institution) or T2SR as the T2-weighted sequence in the reading protocol. The remainder of sequences were the same (axial T1-weighted TSE pre and post contrast administration, axial dynamically contrast enhanced T1, sagittal T2 TSE and axial diffusion weighted sequences with apparent diffusion coefficient map). Cohen's Kappa was used for correlation of readings with inclusion of either T2SR or T2NC.
4 months
Quantitative assessment of image quality (apparent signal-to-noise and contrast-to-noise ratio)
Apparent signal-to-noise ratio (aSNR: signal intensity of peripheral zone/standard deviation of muscle) and contrast-to-noise ratio (aCNR: signal intensity of peripheral zone - signal intensity of muscle)/standard deviation of muscle) was calculated to quantify the image sharpness. One-way ANOVA was used for significance testing with p\<0.05 considered as indicative of a significant difference.
4 months
Quantitative assessment of image quality (edge rise distance)
Edge rise distance (ERD) was calculated to quantify the image sharpness. The ERD was determined as a measure of image sharpness. For this purpose, a line was drawn perpendicularly crossing the dorsal border of the prostate capsule. The edge rise distance was then determined as the distance (in mm) between the 10% and 90% signal intensity levels relative to the low and high signal intensity areas. One-way ANOVA was used for significance testing with p\<0.05 considered as indicative of a significant difference.
4 months
Study Arms (1)
Deep learning based reconstruction of T2-TSE sequence
EXPERIMENTALParticipants undergo multiparametric MRI of the prostate with inclusion of standard cartesian T2-TSE and non-cartesian T2-weighted sequences, as well as a newly developed deep learning enhanced T2-TSE sequence. All patients in this study undergo the same imaging protocol.
Interventions
A newly developed deep-learning based reconstruction of a primarily low-resolved T2-TSE sequence is included in the imaging protocol for evaluation of prostate cancer.
Eligibility Criteria
You may qualify if:
- Clinical suspicion of prostate cancer (PSA \>4 ng/ml or suspicious digital rectal exam/transrectal ultrasound)
You may not qualify if:
- General contraindications for MRI (cardiac pacemakers, neurostimulators, ferric metal) or gadolinium based contrast agents (GFR \<30 ml/min/1.73 m2, prior severe allergic reactions)
- Severe claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bonnlead
- Philips Healthcarecollaborator
Study Sites (1)
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Related Publications (25)
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PMID: 37750774DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julian A Luetkens, PD Dr. med.
University Hospital, Bonn
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiovascular Imaging, Principal Investigator, Senior Physician
Study Record Dates
First Submitted
February 6, 2023
First Posted
April 19, 2023
Study Start
August 1, 2022
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
April 19, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share