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Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging

15 mei 2026 bijgewerkt door: Andreas Habberstad, Oslo University Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Study Coordinator, Department of Urology
Telefoonnummer: +47 22 89 40 00
E-mail: postmottak@ous-hf.no

Studie Locaties

Noorwegen
- - Oslo, Noorwegen
    - Werving
    - Oslo University Hospital
    - Contact:
      
      Study Coordinator, Department of Urology
      
      Telefoonnummer: +47 22 89 40 00
      
      E-mail: postmottak@ous-hf.no
    - Hoofdonderzoeker:
      
      Andreas Habberstad, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

Contraindications to MRI or iodinated contrast media
Prior treatment for bladder cancer
Pregnancy
Non-malignant bladder lesions
Tumors located in bladder diverticula

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2) Tijdsspanne: 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.	From imaging to final histopathological reference standard (up to 12 months)

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Positive and Negative Predictive Values Tijdsspanne: From imaging to final histopathological reference standard (up to 12 months)	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.	From imaging to final histopathological reference standard (up to 12 months)
Interobserver Agreement for MRI and CT Tumor Staging Tijdsspanne: During blinded image evaluation following imaging acquisition	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.	During blinded image evaluation following imaging acquisition
Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT Tijdsspanne: From imaging to final histopathological reference standard (up to 12 months)	Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.	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 Tijdsspanne: From imaging to final histopathological reference standard (up to 12 months)	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.	From imaging to final histopathological reference standard (up to 12 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Oslo University Hospital

Onderzoekers

Hoofdonderzoeker: Andreas Habberstad, MD, PhD, Oslo University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 april 2026

Primaire voltooiing (Geschat)

30 april 2028

Studie voltooiing (Geschat)

31 oktober 2028

Studieregistratiedata

Eerst ingediend

9 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)