Super-fast 3T Prostate MRI Using High Gradient Strength and Deep Learning

NCT ID: NCT06244680

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2023-12-31

Brief Summary

Recent developments in MRI techniques allow ultra-high gradient strength diffusion imaging and deep learning (DL) reconstruction in clinical routine. However, its usability in biparametric MRI (bpMRI) of the prostate has not been well studied. The aim is to establish a super-fast 3-minutes bpMRI protocol at 3 Tesla using high gradient strength and DL reconstruction and compare it against a full, multiparametric MRI (mpMRI) protocol.

Detailed Description

Multiparametric MRI (mpMRI) of the prostate has become the most important non-invasive diagnostic tool for assessment of prostate cancer and is the baseline for MRI targeted biopsy (1,2). As the incidence of prostate cancer is high with an estimated 290,000 new cases for 2023 in the United States alone (3), the need for widespread provision of prostate mpMRI is immense. However, current clinical MRI-protocols are long with acquisition times of >30 minutes, potentially limiting the number of examined patients. According to the guidelines of the Prostate Imaging Reporting and Data System (PI-RADS) a sufficient mpMRI protocol must include diffusion weighted imaging (DWI), T2-weighted (T2w) imaging, dynamic contrast enhanced imaging and T1-weighted imaging pre and post administration of contrast (4,5). Different approaches have been developed to shorten the protocol itself or to accelerate acquisition times. For instance, a significant reduction of T2w-sequence acquisition times was achieved by employing deep learning methods (6) or advancements of compressed sensing (7), while at the same time images had improved quality. Different studies showed equal performance of biparametric MRI (bpMRI) protocols compared to the standard multiparametric protocol, effectively reducing the acquisition time down to 5 minutes (8,9,10). This was done by focusing only on DWI and T2w imaging while omitting the dynamic contrast enhanced sequence and T1-weighted sequences, as the additional diagnostic value of these is supposed to be limited (11).

Recent developments in MRI techniques allow for ultra-high diffusion gradient strengths of up to 500 mT/m and slew rates of up to 600 T/m/s, thus reducing echo times and acquisition times by faster establishment of the diffusion gradient (12,13). Furthermore, these gradients are able to image at small scales with a high signal-to-noise ratio, consecutively enhancing sensitivity for detection of tissue microstructures (14,15). Due to the experimental nature of these gradients, this technique has only been investigated in a research setting in healthy volunteers (16), but not in a real world clinical setting, let alone in prostate imaging.

Therefore, the aim of the study was to establish a super-fast abbreviated bpMRI protocol for patients with suspicion for prostate cancer using both ultra-high gradients and deep learning reconstruction for DWI- and T2w-sequences. Besides the assessment of acquisition times, the main objective of this study was to assess the overall image quality of bpMRI and mpMRI and the influence on PI-RADS scores.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MRI of the prostate

Patients with suspicion for prostate cancer underwent mpMRI on a new 3-Tesla-MRI scanner with a maximum gradient strength of 200 mT/m, a slew rate of 200 T/m/s and DL reconstruction for image postprocessing.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Elevated PSA >4ng/ml or suspicious digitial rectal exam or supicious transrectal ultrasound

Exclusion Criteria

• General MRI contraindications (incompatible cardiac pacemaker, neurostimulators) or allergy for gadolinium-containing contrast media or severe claustrophobie

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Julian Alexander Luetkens

PD Dr. med.; Head of MR-Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julian A Luetkens, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

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Other Identifiers

CX.001

Identifier Type: -

Identifier Source: org_study_id