Bladder CancermetricMRINCT05783271
Validity of Parametric MRI Using VIRADS
A study testing Gadolinium in people with Bladder Cancer, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Gadolinium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 58 cases of patients who suspected to have cancer urinary bladder by clinical, histopathological examination and radiological imaging.
- All age groups . Both sex
Who cannot join
- patient with high renal chemistry. Patient with contraindications to MRI as pacemaker and cochlear implants.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validity of Parametric MRI Using VIRAD Scoring in the Diagnosis of Cancer Bladder
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.
Read the detailed description
Urinary bladder cancer is the second most common neoplasm of the urinary tract worldwide. It accounts for 6-8% of malignancy in men and 2- 3% in women, with the highest incidence rates in North America , Europe and areas with endemic schistosomiasis in Africa and the Middle East.(1) Factors contribute to the development of bladder cancer are: advanced age, male sex, cigarette smoking and parasitic infection with schistosomiasis. Bladder cancer(BC)ranges from unaggressive non-invasive tumor(NMICB) that recur and commit patients to long life surveillance to aggressive and invasive tumors (MICB)with high disease mortality.(2) Knowledge of the clinical, histopathologic, and imaging features of common bladder neoplasms is essential.
The first-line imaging tool for assessing bladder lesions is ultrasonography, which may be followed by a computed tomography or magnetic resonance imaging if the origin of the mass is unclear or if distant spread is suspected.(3) Accurate preoperative diagnosis of detrusor muscle invasion of BC is important because non- muscle-invasive (stage T1 or lower) and muscle-invasive (stage T2 or higher) BC are treated differently.Prognosis of the tumor depends mainly on grade ,depths of invasion and the presence of carcinoma insitu(CIS).(4) MRI now become the modality of choice for the local staging of BC , assessment of regional lymph node involvement and the tumor spread to pelvic bones and upper urinary tract.(5) As it has high tissue contrast, multiplanar imaging capabilities, and the ability of tissue characterization.(6) Currently, the multi-parametric magnetic resonance imaging (mp-MRI) is widely used for bladder cancer diagnosis and staging. It consists of the conventional sequence [T2-weighted anatomic imaging (T2WI)] and functional MRI techniques [dynamic contrast-enhanced (DCE) imaging and diffusion-weighted imaging (DWI)] .(7).With diagnostic accuracy in differentiation between MICB and NMICB was 84% with highest sensitivity 78%.(9) DWI used in mp-MRI is reported as the dominant sequence in evaluating BC muscle invasion .(14) To Avoid contrast material-related complications,the question askesd : Is contrast material important in the local staging of BC ?( 13) So assessing the diagnostic validity of the non contrast biparametric MRI (bpMRI) with that of (mpMRI) based on the Vesicle Imaging-Reporting and Data System (VI-RADS) in predicting muscle invasion by bladder cancer (BCa) is needed.(10). (VIRADS) scoring system was created in 2018 to standardise imaging and reporting of bladder cancer staging with mp- MRI which suggests the likelihood of detruser muscle invasion. Muscle invasion disease carries a worse prognosis and requires radical surgery.(4) VI-RADS provides high diagnostic accuracy to diagnose high grade and muscle invasive bladder cancer.(11)
:Prospectively calculated and collected data will be analysed. Computer software: SPSS package 23 Statistical tests: Descriptive statistics will be performed with frequency and cross tabulations for categorical variables. Means and standard deviations will be measured for numerical variables. The chi-square test will be used for comparing independent categorical variables. Monte Carlo simulations will be run for multiple groups if comparisons will not meet the chi-square criteria; Fishers exact test will be used in the comparison of the groups. Students t-test will be used for comparing the numerical data displaying normal distribution; the MannWhitney U-test will be performed for the numerical variables not displaying normal distribution. The P-value will be set at 0.05 and all of the comparisons will be two-tailed.
- Conditions
- Bladder Cancer
- Being tested
- Gadolinium
- 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.
GadoliniumDiagnostic test
Also called MRI contrast
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 group | Role | What they receive |
|---|---|---|
| mpMRI and biparametric MRI | Experimental | MRI images of the 58 patients with bladder tumors were transferred to a picture archiving communication system (PACS). The images were separated into two groups, namely set 1 (bp-MRI (non-contrast) protocol) and set 2 (mp-MRI protocol). Set 1 images has included three planes T2-WI and axial DWI sequences; set 2 images has included the DCE sequence in addition to set 1. Both of image sets were independently evaluated by a board-certified abdomi nal radiologist with 10 years of experience (reader 1) and general radiologist with 8 years of experience (reader 2). All lesions is scored in accordance with VI-RADS criteria in T2-WI, DWI, and DCE images separately, and the final VI-RADS score was determined. The lesions with VI-RADS scores 1-3 were evaluated as NMIBC, and VI-RADS scores 4 and 5 as MIBC . Receives: Diagnostic Test: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess validity of parametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder
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.
Measured: 2 years
Validity
Aiming for high specificity or sensitivity to achieve the best patient results
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EmanTaha Abo-Elfadl, Assiut University
- Investigators
- Hassan A.Abolella, Proff, Principal investigator, Newvalley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783271
- Sponsor's protocol ID
- universty
- Acronym
- metricMRI
- Status last verified
- Sep 2025
- First submitted
- 2 Mar 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shelmerdine SC, Lorenzo AJ, Gupta AA, Chavhan GB. Pearls and Pitfalls in Diagnosing Pediatric Urinary Bladder Masses. Radiographics. 2017 Oct;37(6):1872-1891. doi: 10.1148/rg.2017170031.
PubMed 29019749Wang H, Luo C, Zhang F, Guan J, Li S, Yao H, Chen J, Luo J, Chen L, Guo Y. Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion. Radiology. 2019 Jun;291(3):668-674. doi: 10.1148/radiol.2019182506. Epub 2019 Apr 23.
PubMed 31012814Rabie E, Faeghi F, Izadpanahi MH, Dayani MA. Role of Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Staging of Bladder Cancer. J Clin Diagn Res. 2016 Apr;10(4):TC01-5. doi: 10.7860/JCDR/2016/17596.7690. Epub 2016 Apr 1.
PubMed 27190913Caglic I, Panebianco V, Vargas HA, Bura V, Woo S, Pecoraro M, Cipollari S, Sala E, Barrett T. MRI of Bladder Cancer: Local and Nodal Staging. J Magn Reson Imaging. 2020 Sep;52(3):649-667. doi: 10.1002/jmri.27090. Epub 2020 Feb 29.
PubMed 32112505Panebianco V, Narumi Y, Altun E, Bochner BH, Efstathiou JA, Hafeez S, Huddart R, Kennish S, Lerner S, Montironi R, Muglia VF, Salomon G, Thomas S, Vargas HA, Witjes JA, Takeuchi M, Barentsz J, Catto JWF. Multiparametric Magnetic Resonance Imaging for Bladder Cancer: Development of VI-RADS (Vesical Imaging-Reporting And Data System). Eur Urol. 2018 Sep;74(3):294-306. doi: 10.1016/j.eururo.2018.04.029. Epub 2018 May 10.
PubMed 29755006Del Giudice F, Flammia RS, Pecoraro M, Moschini M, D'Andrea D, Messina E, Pisciotti LM, De Berardinis E, Sciarra A, Panebianco V. The accuracy of Vesical Imaging-Reporting and Data System (VI-RADS): an updated comprehensive multi-institutional, multi-readers systematic review and meta-analysis from diagnostic evidence into future clinical recommendations. World J Urol. 2022 Jul;40(7):1617-1628. doi: 10.1007/s00345-022-03969-6. Epub 2022 Mar 16.
PubMed 35294583Makboul M, Farghaly S, Abdelkawi IF. Multiparametric MRI in differentiation between muscle invasive and non-muscle invasive urinary bladder cancer with vesical imaging reporting and data system (VI-RADS) application. Br J Radiol. 2019 Dec;92(1104):20190401. doi: 10.1259/bjr.20190401. Epub 2019 Oct 8.
PubMed 31573328Noh TI, Shim JS, Kang SG, Sung DJ, Cheon J, Sim KC, Kang SH. Comparison between biparametric and multiparametric MRI in predicting muscle invasion by bladder cancer based on the VI-RADS. Sci Rep. 2022 Nov 30;12(1):20689. doi: 10.1038/s41598-022-19273-7.
PubMed 36450813Gmeiner J, Garstka N, Helbich TH, Shariat SF, Baltzer PA. Vesical Imaging Reporting and Data System (VI-RADS): Are the individual MRI sequences equivalent in diagnostic performance of high grade NMIBC and MIBC? Eur J Radiol. 2021 Sep;142:109829. doi: 10.1016/j.ejrad.2021.109829. Epub 2021 Jun 24.
PubMed 34252867Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Delli Pizzi A, Mastrodicasa D, Taraschi A, Civitareale N, Mincuzzi E, Censi S, Marchioni M, Primiceri G, Castellan P, Castellucci R, Cocco G, Chiacchiaretta P, Colasante A, Corvino A, Schips L, Caulo M. Conspicuity and muscle-invasiveness assessment for bladder cancer using VI-RADS: a multi-reader, contrast-free MRI study to determine optimal b-values for diffusion-weighted imaging. Abdom Radiol (NY). 2022 May;47(5):1862-1872. doi: 10.1007/s00261-022-03490-9. Epub 2022 Mar 18.
PubMed 35303112Aslan S, Cakir IM, Oguz U, Bekci T, Demirelli E. Comparison of the diagnostic accuracy and validity of biparametric MRI and multiparametric MRI-based VI-RADS scoring in bladder cancer; is contrast material really necessary in detecting muscle invasion? Abdom Radiol (NY). 2022 Feb;47(2):771-780. doi: 10.1007/s00261-021-03383-3. Epub 2021 Dec 17.
PubMed 34919161Saginala K, Barsouk A, Aluru JS, Rawla P, Padala SA, Barsouk A. Epidemiology of Bladder Cancer. Med Sci (Basel). 2020 Mar 13;8(1):15. doi: 10.3390/medsci8010015.
PubMed 32183076Lenis AT, Lec PM, Chamie K, Mshs MD. Bladder Cancer: A Review. JAMA. 2020 Nov 17;324(19):1980-1991. doi: 10.1001/jama.2020.17598.
PubMed 33201207
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Parametric MRI Using VIRAD Scoring in the Diagnosis of Cancer Bladder
- ClinicalTrials.gov ID
- NCT05783271
- Acronym / sponsor ID
- metricMRI / universty
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2023 (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.
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.
Detailed description
Urinary bladder cancer is the second most common neoplasm of the urinary tract worldwide. It accounts for 6-8% of malignancy in men and 2- 3% in women, with the highest incidence rates in North America , Europe and areas with endemic schistosomiasis in Africa and the Middle East.(1) Factors contribute to the development of bladder cancer are: advanced age, male sex, cigarette smoking and parasitic infection with schistosomiasis. Bladder cancer(BC)ranges from unaggressive non-invasive tumor(NMICB) that recur and commit patients to long life surveillance to aggressive and invasive tumors (MICB)with high disease mortality.(2) Knowledge of the clinical, histopathologic, and imaging features of common bladder neoplasms is essential.
The first-line imaging tool for assessing bladder lesions is ultrasonography, which may be followed by a computed tomography or magnetic resonance imaging if the origin of the mass is unclear or if distant spread is suspected.(3) Accurate preoperative diagnosis of detrusor muscle invasion of BC is important because non- muscle-invasive (stage T1 or lower) and muscle-invasive (stage T2 or higher) BC are treated differently.Prognosis of the tumor depends mainly on grade ,depths of invasion and the presence of carcinoma insitu(CIS).(4) MRI now become the modality of choice for the local staging of BC , assessment of regional lymph node involvement and the tumor spread to pelvic bones and upper urinary tract.(5) As it has high tissue contrast, multiplanar imaging capabilities, and the ability of tissue characterization.(6) Currently, the multi-parametric magnetic resonance imaging (mp-MRI) is widely used for bladder cancer diagnosis and staging. It consists of the conventional sequence [T2-weighted anatomic imaging (T2WI)] and functional MRI techniques [dynamic contrast-enhanced (DCE) imaging and diffusion-weighted imaging (DWI)] .(7).With diagnostic accuracy in differentiation between MICB and NMICB was 84% with highest sensitivity 78%.(9) DWI used in mp-MRI is reported as the dominant sequence in evaluating BC muscle invasion .(14) To Avoid contrast material-related complications,the question askesd : Is contrast material important in the local staging of BC ?( 13) So assessing the diagnostic validity of the non contrast biparametric MRI (bpMRI) with that of (mpMRI) based on the Vesicle Imaging-Reporting and Data System (VI-RADS) in predicting muscle invasion by bladder cancer (BCa) is needed.(10). (VIRADS) scoring system was created in 2018 to standardise imaging and reporting of bladder cancer staging with mp- MRI which suggests the likelihood of detruser muscle invasion. Muscle invasion disease carries a worse prognosis and requires radical surgery.(4) VI-RADS provides high diagnostic accuracy to diagnose high grade and muscle invasive bladder cancer.(11)
:Prospectively calculated and collected data will be analysed. Computer software: SPSS package 23 Statistical tests: Descriptive statistics will be performed with frequency and cross tabulations for categorical variables. Means and standard deviations will be measured for numerical variables. The chi-square test will be used for comparing independent categorical variables. Monte Carlo simulations will be run for multiple groups if comparisons will not meet the chi-square criteria; Fishers exact test will be used in the comparison of the groups. Students t-test will be used for comparing the numerical data displaying normal distribution; the MannWhitney U-test will be performed for the numerical variables not displaying normal distribution. The P-value will be set at 0.05 and all of the comparisons will be two-tailed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mpMRI and biparametric MRI | Experimental | Diagnostic Test: GadoliniumMRI images of the 58 patients with bladder tumors were transferred to a picture archiving communication system (PACS). The images were separated into two groups, namely set 1 (bp-MRI (non-contrast) protocol) and set 2 (mp-MRI protocol). Set 1 images has included three planes T2-WI and axial DWI sequences; set 2 images has included the DCE sequence in addition to set 1. Both of image sets were independently evaluated by a board-certified abdomi nal radiologist with 10 years of experience (reader 1) and general radiologist with 8 years of experience (reader 2). All lesions is scored in accordance with VI-RADS criteria in T2-WI, DWI, and DCE images separately, and the final VI-RADS score was determined. The lesions with VI-RADS scores 1-3 were evaluated as NMIBC, and VI-RADS scores 4 and 5 as MIBC . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 58 cases of patients who suspected to have cancer urinary bladder by clinical, histopathological examination and radiological imaging.
- All age groups . Both sex
Key exclusion criteria (2 listed)
- patient with high renal chemistry. Patient with contraindications to MRI as pacemaker and cochlear implants.
- -
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 |
|---|---|---|
| GadoliniumAlso: MRI contrastAll 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. | Diagnostic test | mpMRI and biparametric MRI |
Primary outcome
To assess validity of parametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder
Time frame: 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
Time frame: 2 years
Aiming for high specificity or sensitivity to achieve the best patient results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 29019749Shelmerdine SC, Lorenzo AJ, Gupta AA, Chavhan GB. Pearls and Pitfalls in Diagnosing Pediatric Urinary Bladder Masses. Radiographics. 2017 Oct;37(6):1872-1891. doi: 10.1148/rg.2017170031.
- Background: PubMed 31012814Wang H, Luo C, Zhang F, Guan J, Li S, Yao H, Chen J, Luo J, Chen L, Guo Y. Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion. Radiology. 2019 Jun;291(3):668-674. doi: 10.1148/radiol.2019182506. Epub 2019 Apr 23.
- Background: PubMed 27190913Rabie E, Faeghi F, Izadpanahi MH, Dayani MA. Role of Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Staging of Bladder Cancer. J Clin Diagn Res. 2016 Apr;10(4):TC01-5. doi: 10.7860/JCDR/2016/17596.7690. Epub 2016 Apr 1.
- Background: PubMed 32112505Caglic I, Panebianco V, Vargas HA, Bura V, Woo S, Pecoraro M, Cipollari S, Sala E, Barrett T. MRI of Bladder Cancer: Local and Nodal Staging. J Magn Reson Imaging. 2020 Sep;52(3):649-667. doi: 10.1002/jmri.27090. Epub 2020 Feb 29.
- Background: PubMed 29755006Panebianco V, Narumi Y, Altun E, Bochner BH, Efstathiou JA, Hafeez S, Huddart R, Kennish S, Lerner S, Montironi R, Muglia VF, Salomon G, Thomas S, Vargas HA, Witjes JA, Takeuchi M, Barentsz J, Catto JWF. Multiparametric Magnetic Resonance Imaging for Bladder Cancer: Development of VI-RADS (Vesical Imaging-Reporting And Data System). Eur Urol. 2018 Sep;74(3):294-306. doi: 10.1016/j.eururo.2018.04.029. Epub 2018 May 10.
- Background: PubMed 35294583Del Giudice F, Flammia RS, Pecoraro M, Moschini M, D'Andrea D, Messina E, Pisciotti LM, De Berardinis E, Sciarra A, Panebianco V. The accuracy of Vesical Imaging-Reporting and Data System (VI-RADS): an updated comprehensive multi-institutional, multi-readers systematic review and meta-analysis from diagnostic evidence into future clinical recommendations. World J Urol. 2022 Jul;40(7):1617-1628. doi: 10.1007/s00345-022-03969-6. Epub 2022 Mar 16.
- Background: PubMed 31573328Makboul M, Farghaly S, Abdelkawi IF. Multiparametric MRI in differentiation between muscle invasive and non-muscle invasive urinary bladder cancer with vesical imaging reporting and data system (VI-RADS) application. Br J Radiol. 2019 Dec;92(1104):20190401. doi: 10.1259/bjr.20190401. Epub 2019 Oct 8.
- Background: PubMed 36450813Noh TI, Shim JS, Kang SG, Sung DJ, Cheon J, Sim KC, Kang SH. Comparison between biparametric and multiparametric MRI in predicting muscle invasion by bladder cancer based on the VI-RADS. Sci Rep. 2022 Nov 30;12(1):20689. doi: 10.1038/s41598-022-19273-7.
- Background: PubMed 34252867Gmeiner J, Garstka N, Helbich TH, Shariat SF, Baltzer PA. Vesical Imaging Reporting and Data System (VI-RADS): Are the individual MRI sequences equivalent in diagnostic performance of high grade NMIBC and MIBC? Eur J Radiol. 2021 Sep;142:109829. doi: 10.1016/j.ejrad.2021.109829. Epub 2021 Jun 24.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 35303112Delli Pizzi A, Mastrodicasa D, Taraschi A, Civitareale N, Mincuzzi E, Censi S, Marchioni M, Primiceri G, Castellan P, Castellucci R, Cocco G, Chiacchiaretta P, Colasante A, Corvino A, Schips L, Caulo M. Conspicuity and muscle-invasiveness assessment for bladder cancer using VI-RADS: a multi-reader, contrast-free MRI study to determine optimal b-values for diffusion-weighted imaging. Abdom Radiol (NY). 2022 May;47(5):1862-1872. doi: 10.1007/s00261-022-03490-9. Epub 2022 Mar 18.
- Background: PubMed 34919161Aslan S, Cakir IM, Oguz U, Bekci T, Demirelli E. Comparison of the diagnostic accuracy and validity of biparametric MRI and multiparametric MRI-based VI-RADS scoring in bladder cancer; is contrast material really necessary in detecting muscle invasion? Abdom Radiol (NY). 2022 Feb;47(2):771-780. doi: 10.1007/s00261-021-03383-3. Epub 2021 Dec 17.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
Urinary Bladder Cancer
Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Advanced Bladder Urothelial Carcinoma, Advanced Renal Pelvis Urothelial Carcinoma
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.
Hassan A.Abolella, Proff principal investigator
Newvalley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gadolinium in people with Bladder Cancer, run by Assiut University 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassan Megally, proff (01006209584, hasanibrahim48@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess validity of parametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783271, which also lists 14 linked publications.
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 2 Oct 2025.