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

15 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

150

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Study Coordinator, Department of Urology
Telefonnummer: +47 22 89 40 00
E-post: postmottak@ous-hf.no

Studieorter

Norge
- - Oslo, Norge
    - Rekrytering
    - Oslo University Hospital
    - Kontakt:
      
      Study Coordinator, Department of Urology
      
      Telefonnummer: +47 22 89 40 00
      
      E-post: postmottak@ous-hf.no
    - Huvudutredare:
      
      Andreas Habberstad, MD, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2) Tidsram: 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)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Positive and Negative Predictive Values Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Oslo University Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 april 2026

Primärt slutförande (Beräknad)

30 april 2028

Avslutad studie (Beräknad)

31 oktober 2028

Studieregistreringsdatum

Först inskickad

9 maj 2026

Först inskickad som uppfyllde QC-kriterierna

15 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)