Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Study Coordinator, Department of Urology
- Telefonnummer: +47 22 89 40 00
- E-Mail: postmottak@ous-hf.no
Studienorte
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Oslo, Norwegen
- Rekrutierung
- Oslo University Hospital
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Kontakt:
- Study Coordinator, Department of Urology
- Telefonnummer: +47 22 89 40 00
- E-Mail: postmottak@ous-hf.no
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Hauptermittler:
- Andreas Habberstad, MD, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)
Zeitfenster: From imaging to final histopathological reference standard (up to 12 months)
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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.
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From imaging to final histopathological reference standard (up to 12 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Positive and Negative Predictive Values
Zeitfenster: From imaging to final histopathological reference standard (up to 12 months)
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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.
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From imaging to final histopathological reference standard (up to 12 months)
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Interobserver Agreement for MRI and CT Tumor Staging
Zeitfenster: During blinded image evaluation following imaging acquisition
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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.
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During blinded image evaluation following imaging acquisition
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Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT
Zeitfenster: From imaging to final histopathological reference standard (up to 12 months)
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Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.
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From imaging to final histopathological reference standard (up to 12 months)
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Diagnostic accuracy of MRI and CT for detection of muscle-invasive bladder cancer within tumor subgroups
Zeitfenster: From imaging to final histopathological reference standard (up to 12 months)
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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.
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From imaging to final histopathological reference standard (up to 12 months)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Andreas Habberstad, MD, PhD, Oslo University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Männliche Urogenitalerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Neubildungen nach histologischem Typ
- Neubildungen, Drüsen und Epithelien
- Urologische Neubildungen
- Karzinom
- Erkrankungen der Harnblase
- Nicht-muskelinvasive Blasenneoplasien
- Neoplasien der Harnblase
- Karzinom, Übergangszelle
Andere Studien-ID-Nummern
- 970903
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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