NCT04167631

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

5.9 years

First QC Date

November 15, 2019

Last Update Submit

October 28, 2024

Conditions

MRI Contrast Media Adverse ReactionBladder CancerBladder DiseaseBladder NeoplasmBladder Urothelial CarcinomaBladder Cancer StageDiagnoses Disease

Keywords

VI-RADSMultiparametric MRINon-muscle invasive bladder cancer (NMIBC)Muscle invasive bladder cancer (MIBC)

Outcome Measures

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)

    18 months

Study Arms (1)

Multiparametric MRI

OTHER

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

Radiation: Multi-parametric MRI

Interventions

Multi-parametric MRIRADIATION

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
Multiparametric MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • fungating lesions
  • beyond the scope of enbloc resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrinary Bladder DiseasesNon-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Ahmed Mosbah, MD

    Mansoura University

    STUDY CHAIR

  • Mohammed Aboelghar, MD

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

January 1, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)