Bladder CancerNCT05123404
Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
A study testing multi parametric MRI and transurethral resection of bladder tumor in people with Bladder Cancer, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- multi parametric MRI and transurethral resection of bladder tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Nov 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patients with bladder mass diagnosed by U/S ,CT or MRI and scheduled for cystoscopy
Who cannot join
- • Patients with general contraindication for MRI examination (as metallic prosthesis, pacemaker or claustrophobia).
- Patients with contraindication for transurethral resection (TUR) (as those unfit for anesthesia).
- Patients with high renal functions, as they are contraindicated for dynamic contrast enhancing imaging.
- Patients there histopathology proved that their bladder mass not TCC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.
Read the detailed description
Bladder cancer (BC) is one of the most common and expensive human malignancies to manage. Most BCs are urothelial cell carcinomas (UCCs), and histologically stratified into cancers with low and high grade. The latter are subdivided into those with and without muscle invasion.(1) Non-muscle-invasive BCs (NMIBCs) are often low grade and have an indolent natural history. Muscle-invasive BCs (MIBCs) are aggressive tumors with an ominous prognosis. (2) Non-muscle invasive bladder cancer is treated with transurethral resection of bladder tumor with or without adjuvant intravesical chemotherapy or photodynamic therapy, whereas muscle-invasive bladder cancer is treated with radical cystectomy, radiation therapy, chemotherapy, or a combination(3).
Bladder cancer staging is accomplished by the combination of clinical (examination), pathologic (transurethral resection of bladder tumor specimens), and radiologic means. The quality of the transurethral resection of bladder tumors often varies among surgeons, and it may miss muscle infiltration in up to 25% of invasive cancers. (4) Radiological examination looks for second urinary tract malignancies (5% of BCs may have an upper tract UCC) or other pathologies. Most guidelines suggest cross-sectional imaging for MIBCs and high-grade NMI cancers, due to the risks of invasion and regional or distant metastases, and upper urinary tract involvement. (5) MRI is currently the best imaging technique for bladder cancer local regional staging because of its superior soft tissue contrast, lack of ionizing radiation, in addition, it clearly differentiates the layer of bladder wall and enables accurate assessment of tumor depth invasion in bladder wall and extra-vesical extension. (6) During the past few years, important improvements in MRI technology have been achieved and led to the introduction of Multiparametric MRI (mp MRI) which combines functional sequences as diffusion weighted imaging (DWI) and dynamic contrast enhanced MRI (DCE-MR) with anatomic T1 and T2 weighted images (T1 and T2WI), that improves the accuracy of tumor detection and staging, helps to monitor post-therapy response and identify local disease recurrence. (7) Recently also standardized approach for imaging and reporting mp-MRI for bladder cancer was created by developing VI-RADS score (Vesical Imaging Reporting and Data System). This aims to standardize bladder mpMRI for clinical and research applications to create a systematic approach for reporting bladder mp-MRI and defining the risk of muscle invasion (NMIBC versus MIBC). (8) The Final VI-RADS score is generated using all categories and suggests the probability of muscle invasion ,It's graded from VIRADS 1 (muscle invasion is highly unlikely) to VI-RADS 5 (ivasion of muscle and beyond the bladder is very likely) (9) In our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score.
2- AIM:
To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.
- Conditions
- Bladder Cancer
- Being tested
- multi parametric MRI, transurethral resection of bladder tumor
- Keywords
- bladder cancer, MRI ,Vi RADS ,
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi parametric MRIDiagnostic test
In our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score.
transurethral resection of bladder tumorProcedure or surgery
detection of degree of invasion to test accuracy of ViRADS score
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Patients will undergo MRI followed by TURBT Receives: Diagnostic Test: multi parametric MRI; Procedure: transurethral resection of bladder tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of ViRADS SCORE
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start4 Nov 2021
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Ahmed Tawfeek, Egyptian Biomedical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123404
- Sponsor's protocol ID
- FMASU MS293/2021
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
- ClinicalTrials.gov ID
- NCT05123404
- Acronym / sponsor ID
- FMASU MS293/2021
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, MRI ,Vi RADS ,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Collaborators
- Ain Shams University
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.
Detailed description
Bladder cancer (BC) is one of the most common and expensive human malignancies to manage. Most BCs are urothelial cell carcinomas (UCCs), and histologically stratified into cancers with low and high grade. The latter are subdivided into those with and without muscle invasion.(1) Non-muscle-invasive BCs (NMIBCs) are often low grade and have an indolent natural history. Muscle-invasive BCs (MIBCs) are aggressive tumors with an ominous prognosis. (2) Non-muscle invasive bladder cancer is treated with transurethral resection of bladder tumor with or without adjuvant intravesical chemotherapy or photodynamic therapy, whereas muscle-invasive bladder cancer is treated with radical cystectomy, radiation therapy, chemotherapy, or a combination(3).
Bladder cancer staging is accomplished by the combination of clinical (examination), pathologic (transurethral resection of bladder tumor specimens), and radiologic means. The quality of the transurethral resection of bladder tumors often varies among surgeons, and it may miss muscle infiltration in up to 25% of invasive cancers. (4) Radiological examination looks for second urinary tract malignancies (5% of BCs may have an upper tract UCC) or other pathologies. Most guidelines suggest cross-sectional imaging for MIBCs and high-grade NMI cancers, due to the risks of invasion and regional or distant metastases, and upper urinary tract involvement. (5) MRI is currently the best imaging technique for bladder cancer local regional staging because of its superior soft tissue contrast, lack of ionizing radiation, in addition, it clearly differentiates the layer of bladder wall and enables accurate assessment of tumor depth invasion in bladder wall and extra-vesical extension. (6) During the past few years, important improvements in MRI technology have been achieved and led to the introduction of Multiparametric MRI (mp MRI) which combines functional sequences as diffusion weighted imaging (DWI) and dynamic contrast enhanced MRI (DCE-MR) with anatomic T1 and T2 weighted images (T1 and T2WI), that improves the accuracy of tumor detection and staging, helps to monitor post-therapy response and identify local disease recurrence. (7) Recently also standardized approach for imaging and reporting mp-MRI for bladder cancer was created by developing VI-RADS score (Vesical Imaging Reporting and Data System). This aims to standardize bladder mpMRI for clinical and research applications to create a systematic approach for reporting bladder mp-MRI and defining the risk of muscle invasion (NMIBC versus MIBC). (8) The Final VI-RADS score is generated using all categories and suggests the probability of muscle invasion ,It's graded from VIRADS 1 (muscle invasion is highly unlikely) to VI-RADS 5 (ivasion of muscle and beyond the bladder is very likely) (9) In our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score.
2- AIM:
To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Diagnostic Test: multi parametric MRI, Procedure: transurethral resection of bladder tumorPatients will undergo MRI followed by TURBT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients with bladder mass diagnosed by U/S ,CT or MRI and scheduled for cystoscopy
Key exclusion criteria (4 listed)
- • Patients with general contraindication for MRI examination (as metallic prosthesis, pacemaker or claustrophobia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi parametric MRIIn our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score. | Diagnostic test | intervention arm |
| transurethral resection of bladder tumordetection of degree of invasion to test accuracy of ViRADS score | Procedure or surgery | intervention arm |
Primary outcome
sensitivity and specificity of ViRADS SCORE
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi parametric MRI and transurethral resection of bladder tumor in people with Bladder Cancer, run by Egyptian Biomedical Research Network at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed Tawfeek, ass. Professor (+201005664873, drahmedtawfeek@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of ViRADS SCORE (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.