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

NCT06244680 | Completed FDA Device

• 1 other identifier: CX.001
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Agreement of PI-RADS scores

  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

  Acquisition times for the whole biparametric and whole multiparametric protocol was measured.

  January - February 2024

• Image quality

  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

Interventions

MRI of the prostate DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Related Publications (17)

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  BACKGROUND

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  PMID: 39614012 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Julian A Luetkens, PD Dr. med

  University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.; Head of MR-Imaging

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: November 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)