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Recruiting Not applicable

Validity of Parametric MRI Using VIRADS

NCT05783271 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2025-10-02

Condition(s) studied

Bladder Cancer

Investigational drug(s) / intervention(s)

Gadolinium

Gadolinium: 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 summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 58 cases of patients who suspected to have cancer urinary bladder by clinical, histopathological examination and radiological imaging. All age groups . Both sex Exclusion Criteria: patient with high renal chemistry. Patient with contraindications to MRI as pacemaker and cochlear implants. \-

Primary outcome measure(s)

  • To assess validity of parametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder — 2 years
    in this cohort study ,we will examine patients refered to radiology department Assuit university hospital by mpMRI from 1/3/2025 untill 31/12/2026 then all data will be regrouped to know: Is bi-parametric-MRI protocol has a diagnostic accuracy comparable to an mp-MRI protocol for the detection of muscle invasive BC using the VI-RADS criteria.
  • Validity — 2 years
    Aiming for high specificity or sensitivity to achieve the best patient results

Trial sites (1)

FacilityCityRegionStatus
Assuit university Asyut Assuit Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05783271 on ClinicalTrials.gov ↗ ← All trials in Egypt