Can VI-RADS/ADC Accurately Stage Bladder Cancer?? | NCT04167631

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

NCT04167631

Sponsor

Mansoura University

Status

Active, not recruiting

Last Update Posted

Oct 30, 2024Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

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

Interventions

Multi-parametric MRI

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Nov 15, 2019

First Submission Date that Met QC Criteria

Nov 15, 2019

First Posted Date

Nov 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2024

Last Update Posted Date

Oct 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

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

Conditions Module

Conditions

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiparametric MRI	Other	Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI.	Radiation: Multi-parametric MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-parametric MRI	Radiation	Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.	Multiparametric MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

fungating lesions
beyond the scope of enbloc resection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Mosbah, MD	Mansoura University	Study Chair
Mohammed Aboelghar, MD	Mansoura University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center		Al Mansurah	Aldakahlia	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms
D001745	Urinary Bladder Diseases
D000093284	Non-Muscle Invasive Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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