Validity of Parametric MRI Using VIRADS

Sponsor
Assiut University
Study ID
NCT05783271
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gadolinium — DIAGNOSTIC_TEST
    All patients will be subjected to : MRI examinations on a 1.5-T MRI system in the supine position by using a 16-channel pelvic phased-array coil. The MRI proto col includes the following sequences: unenhanced axial T1-WI, high-resolution three planes (axial, coronal, and sagittal) T2-WI, axial DWI with b values of 0, 800, and 1600 s/mm2, axial DCE T1-WI with three-dimensional (3D) high temporal resolution. In all sequences, the small field of view (FOV) was used with the scope of viewing the entire bladder, proximal urethra, distal ureteral orifices, and adjacent pelvic organs. Gadopentetate dimeglumine (Gadovist, 0.1 ml/kg body weight) is administered at a rate of 2 ml/s using a power injector.

Study Details

Our aim in this prospective study is to evaluate the validity of the non-contrast biparametric MRI (bp-MRI), including T2-WI and DWI sequences, and the availability of an alternative to the mp-MRI, for the muscle invasiveness assessment of bladder cancer using VIRAD scoring in both techniques.

Key Dates

First listed
Mar 24, 2023
Start date
Dec 1, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: mpMRI and biparametric MRI
    MRI images of the 58 patients with bladder tumors were transferred to a picture archiving communication system (PACS). The images were separated into two groups, namely set 1 (bp-MRI (non-contrast) protocol) and set 2 (mp-MRI protocol). Set 1 images has included three planes T2-WI and axial DWI sequences; set 2 images has included the DCE sequence in addition to set 1. Both of image sets were independently evaluated by a board-certified abdomi nal radiologist with 10 years of experience (reader 1) and general radiologist with 8 years of experience (reader 2). All lesions is scored in accordance with VI-RADS criteria in T2-WI, DWI, and DCE images separately, and the final VI-RADS score was determined. The lesions with VI-RADS scores 1-3 were evaluated as NMIBC, and VI-RADS scores 4 and 5 as MIBC .

Primary Outcome Measure

To assess validity of parametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder [ Time Frame: 2 years ]

Central Contacts

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