ClinicalTrials.gg
Active, not recruitingNCT04167631Updated Oct 30, 2024

Can VI-RADS/ADC Accurately Stage Bladder Cancer??

An interventional study of Multi-parametric MRI in MRI Contrast Media Adverse Reaction, Bladder Cancer and Bladder Disease, sponsored by Mansoura University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.

Primary conditionNon-Muscle Invasive Bladder NeoplasmsRegistry: Urinary Bladder NeoplasmsReclassifiedWhy we changed it
Registry
Urinary Bladder Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Non-Muscle Invasive Bladder Neoplasms
Why
  1. The study's title name Non-Muscle Invasive Bladder Neoplasms, a narrower term within Urinary Bladder Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mansoura University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as active, not recruiting.
  • Registered 10 months after the study started (first participant enrolled Jan 2019, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

Read the detailed description

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS

02

Conditions studied

  • MRI Contrast Media Adverse Reaction
  • Bladder Cancer
  • Bladder Disease
  • Bladder Neoplasm
  • Bladder Urothelial Carcinoma
  • Bladder Cancer Stage
  • Diagnoses Disease

Keywords

  • VI-RADS
  • Multiparametric MRI
  • Non-muscle invasive bladder cancer (NMIBC)
  • Muscle invasive bladder cancer (MIBC)
03

In context

Non-Muscle Invasive Bladder Neoplasms Reclassified

294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.

This study's planned enrollment of 150 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.

Browse Non-Muscle Invasive Bladder Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Non-Muscle Invasive Bladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Bladder Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour

Exclusion criteria

Exclusion Criteria:

  • fungating lesions
  • beyond the scope of enbloc resection
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Multiparametric MRI

    Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI.

    Radiation: Multi-parametric MRI

Interventions

  • RadiationMulti-parametric MRI

    Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.

    Also known as: MP-MRI

06

What researchers measure

Primary outcomes

  1. Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.

    assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT)

    Time frame: 18 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Dec 2024, 71 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2019
First posted
Nov 19, 2019
StartActual
Jan 1, 2019
Primary completionEst.
Dec 1, 2024
CompletionEst.
Dec 2024
Last update
Oct 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04167631
Responsible party
Mahmoud Laymon (Principal Investigator, Mansoura University) — Principal investigator
First posted
Nov 19, 2019
Start date
Jan 1, 2019
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 30, 2024

Study contacts

Ahmed Mosbah, MD
study chair · Mansoura University
Mohammed Aboelghar, MD
study director · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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