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

January 29, 2024 updated by: Julian Alexander Luetkens, University Hospital, Bonn

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bonn, NRW, Germany, 53127
        • University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of male patients with clinical suspicion for prostate cancer, as described by the inclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of PI-RADS scores
Time Frame: January - February 2024
Three radiologists with 3, 11 and 12 years of experience in prostate MRI read separately and blinded to personal and clinical parameters (name, age, patient history, value of the prostate specific antigen, clinical examination and transrectal ultrasound) the full bpMRI protocol and graded the lesions according to the PI-RADS classification. Per patient, only the highest graded lesion and its respective prostate zone was noted. If there were two distinct lesions with the highest PI-RADS score in both the peripheral and transitional zone, both were noted. After a washout period of one month all readers did the same for the mpMRI protocol. Both the agreement of biparametric and multiparametric MRI PI-RADS scores for the whole prostate, and for the specific zonal distribution (peripheral and transitional zone) were assessed by calculation of Cohens's κ, interpreted as follows: <0.5 = poor; 0.5-0.75 = moderate; 0.75-0.9 = good; >0.9 = excellent.
January - February 2024
Acquisition time
Time Frame: January - February 2024
Acquisition times for the whole biparametric and whole multiparametric protocol was measured.
January - February 2024
Image quality
Time Frame: January - February 2024
Two raters with 3 and 11 years of experience rated the bpMRI protocol on a five point Likert scale in six different qualitative categories (artifacts, image sharpness, lesion conspicuity, capsule delineation, overall image sharpness and diagnostic confidence). The grades were defined as follows: 1, non-diagnostic due to extensive artifacts, strongly impaired conspicuity of anatomical structures and no diagnostic confidence; 2, several artifacts, difficult conspicuity of anatomical structures and low diagnostic confidence; 3, moderate artifacts, fair conspicuity of anatomical structures and moderate diagnostic confidence; 4, little artifacts, good conspicuity of anatomical structures and good diagnostic confidence; 5, no artifacts, excellent conspicuity of anatomical structures and high diagnostic confidence. Results of both raters were averaged.
January - February 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Julian A Luetkens, PD Dr. med, University of Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CX.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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