Bladder CancerNCT07602010
Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
An observational study of Bladder Cancer and Urothelial Carcinoma (UC), run by Oslo University Hospital at 1 site in Norway.
Trial summary
This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma (UC), Muscle Invasive Bladder Cancer (MIBC)
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 22 Apr 2026to 31 Oct 2028
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with newly diagnosed bladder cancer identified on cystoscopy at a tertiary referral hospital. Eligible participants are patients planned for transurethral resection of the bladder tumor (TURBT) and/or cystectomy as part of standard clinical care, and who are able to undergo both contrast-enhanced computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) prior to definitive histopathological assessment. Patients are included irrespective of tumor stage or grade at presentation, provided that imaging is performed within the defined preoperative diagnostic pathway. Patients with prior bladder cancer treatment or contraindications to imaging are excluded.
Who may be able to join
- Age ≥ 18 years
- Newly diagnosed bladder cancer on cystoscopy
- Planned TURBT or cystectomy within 6 weeks
- Eligible for both CT and MRI within 6 weeks
- Written informed consent provided
Who cannot join
- Contraindications to MRI or iodinated contrast media
- Prior treatment for bladder cancer
- Pregnancy
- Non-malignant bladder lesions
- Tumors located in bladder diverticula
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Study Coordinator, Department of Urology, +47 22 89 40 00, postmottak@ous-hf.no
Andreas Habberstad, MD, PhD
About this study
Official title: Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.
Read the detailed description
Accurate local staging is crucial for distinguishing non-muscle-invasive from muscle-invasive bladder cancer and guiding treatment decisions. While CT is widely used in clinical practice, MRI with VI-RADS has demonstrated higher diagnostic performance in previous retrospective and meta-analytic studies. However, prospective paired comparisons in the same patients are limited.
In this single-center prospective study, newly diagnosed bladder cancer patients undergo cystoscopy, contrast-enhanced CT, and multiparametric MRI prior to definitive histopathological sampling. Two radiologists independently assess imaging in a blinded research setting. Diagnostic performance of MRI and CT is compared using paired statistical analyses, with additional evaluation of interobserver agreement and tumor characteristics.
- Conditions
- Bladder Cancer, Urothelial Carcinoma (UC), Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer
- Keywords
- MRI, Computed Tomography, VI-RADS, Local Staging, Diagnostic Accuracy
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Imaging Comparison Group | All participants undergo contrast-enhanced CT and multiparametric MRI (VI-RADS) as part of routine diagnostic work-up prior to transurethral resection of the bladder tumor or cystectomy. Imaging findings are compared with histopathology for assessment of diagnostic accuracy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)
The primary outcome is the diagnostic accuracy of multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) compared with contrast-enhanced computed tomography (CT) for the detection of muscle-invasive bladder cancer (pathological stage ≥T2). Sensitivity and specificity will be calculated using histopathology from transurethral resection of the bladder tumor, re-TURBT, and/or cystectomy as the reference standard.
Measured: From imaging to final histopathological reference standard (up to 12 months)
Secondary outcomes (4)
Positive and Negative Predictive Values
Positive predictive value (PPV) and negative predictive value (NPV) of MRI (VI-RADS) and CT for detection of muscle-invasive bladder cancer (≥T2), calculated using histopathology as the reference standard.
Measured: From imaging to final histopathological reference standard (up to 12 months)
Interobserver Agreement for MRI and CT Tumor Staging
Interobserver agreement between two independent radiologists for MRI VI-RADS scoring and CT-based T-stage assessment, quantified using weighted kappa statistics in a blinded research reading setting.
Measured: During blinded image evaluation following imaging acquisition
Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT
Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.
Measured: From imaging to final histopathological reference standard (up to 12 months)
Diagnostic accuracy of MRI and CT for detection of muscle-invasive bladder cancer within tumor subgroups
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI and CT for detection of muscle-invasive bladder cancer, assessed within predefined tumor subgroups (tumor size, morphology, tumor location and multiplicity), using histopathology as the reference standard.
Measured: From imaging to final histopathological reference standard (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start22 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Oct 2028 (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.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Habberstad, Oslo University Hospital
- Investigators
- Andreas Habberstad, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602010
- Sponsor's protocol ID
- 970903
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
- ClinicalTrials.gov ID
- NCT07602010
- Acronym / sponsor ID
- 970903
- Conditions
- Bladder Cancer, Urothelial Carcinoma (UC), Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer
- Keywords
- MRI, Computed Tomography, VI-RADS, Local Staging, Diagnostic Accuracy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 22 May 2026 (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.
This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.
Detailed description
Accurate local staging is crucial for distinguishing non-muscle-invasive from muscle-invasive bladder cancer and guiding treatment decisions. While CT is widely used in clinical practice, MRI with VI-RADS has demonstrated higher diagnostic performance in previous retrospective and meta-analytic studies. However, prospective paired comparisons in the same patients are limited.
In this single-center prospective study, newly diagnosed bladder cancer patients undergo cystoscopy, contrast-enhanced CT, and multiparametric MRI prior to definitive histopathological sampling. Two radiologists independently assess imaging in a blinded research setting. Diagnostic performance of MRI and CT is compared using paired statistical analyses, with additional evaluation of interobserver agreement and tumor characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging Comparison Group | – | –All participants undergo contrast-enhanced CT and multiparametric MRI (VI-RADS) as part of routine diagnostic work-up prior to transurethral resection of the bladder tumor or cystectomy. Imaging findings are compared with histopathology for assessment of diagnostic accuracy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with newly diagnosed bladder cancer identified on cystoscopy at a tertiary referral hospital. Eligible participants are patients planned for transurethral resection of the bladder tumor (TURBT) and/or cystectomy as part of standard clinical care, and who are able to undergo both contrast-enhanced computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) prior to definitive histopathological assessment. Patients are included irrespective of tumor stage or grade at presentation, provided that imaging is performed within the defined preoperative diagnostic pathway. Patients with prior bladder cancer treatment or contraindications to imaging are excluded.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Newly diagnosed bladder cancer on cystoscopy
- Planned TURBT or cystectomy within 6 weeks
- Eligible for both CT and MRI within 6 weeks
- Written informed consent provided
Key exclusion criteria (5 listed)
- Contraindications to MRI or iodinated contrast media
- Prior treatment for bladder cancer
- Pregnancy
- Non-malignant bladder lesions
- Tumors located in bladder diverticula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)
Time frame: From imaging to final histopathological reference standard (up to 12 months)
The primary outcome is the diagnostic accuracy of multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) compared with contrast-enhanced computed tomography (CT) for the detection of muscle-invasive bladder cancer (pathological stage ≥T2). Sensitivity and specificity will be calculated using histopathology from transurethral resection of the bladder tumor, re-TURBT, and/or cystectomy as the reference standard.
4 secondary outcomes
Positive and Negative Predictive Values
Time frame: From imaging to final histopathological reference standard (up to 12 months)
Interobserver Agreement for MRI and CT Tumor Staging
Time frame: During blinded image evaluation following imaging acquisition
Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT
Time frame: From imaging to final histopathological reference standard (up to 12 months)
Diagnostic accuracy of MRI and CT for detection of muscle-invasive bladder cancer within tumor subgroups
Time frame: From imaging to final histopathological reference standard (up to 12 months)
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 22 May 2026.
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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.
Andreas Habberstad, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urothelial Carcinoma (UC), run by Oslo University Hospital at 1 site in Norway.
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 5 inclusion and 5 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 22 May 2026. 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 Norway. 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 Study Coordinator, Department of Urology (+47 22 89 40 00, postmottak@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2) (time frame: From imaging to final histopathological reference standard (up to 12 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 22 May 2026.