Diagnostic Performance of Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Bladder Tumour for Prediction of Muscle Invasion and Detection of Residual Tumour in Non-muscle-invasive Bladder Cancer Patients
Urinary Bladder Cancer · NMIBC · TURBT · Vi-Rads
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 86 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
SMART-BC is a prospective, single-centre clinical investigation evaluating the diagnostic performance of multiparametric magnetic resonance imaging (mpMRI) for detecting residual bladder tumour and predicting muscle invasion in patients with non-muscle-invasive bladder cancer (NMIBC).
The study comprises two work packages. WP1 will include 20 healthy volunteers to optimize the bladder MRI protocol using additional clinical sequences without contrast injection, assessing image quality through quantitative and qualitative metrics. WP2 will enrol up to 66 patients with newly diagnosed bladder lesions and suspicious or high-grade urinary cytology, aiming to obtain 33 evaluable patients who undergo pre- and post-transurethral resection of bladder tumour (TURBT) MRI and repeat TURBT (re-TURBT), when clinically indicated.
In WP2, mpMRI will be performed before initial TURBT and approximately 3-4 weeks afterwards in patients requiring re-TURBT. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value and negative predictive value, with histopathology as the reference standard. Standard VI-RADS sequences will be compared with an optimized protocol incorporating additional sequences. Secondary objectives include inter-reader agreement, patient-reported comfort and satisfaction, and preliminary evaluation of healthcare costs and the potential to avoid unnecessary re-TURBT procedures. Safety will be assessed through the systematic collection of adverse events, serious adverse events and device deficiencies.
The investigation uses CE-marked 3T MRI systems and follows routine clinical management pathways. Its long-term aim is to determine whether post-TURBT mpMRI can improve diagnostic assessment and support more personalized management of patients with high-risk NMIBC.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- All adult patients with bladder lesion at cystoscopy and indication for a TURBT, and with a urinary cytology positive or suspicious for atypia or high grade (HG) urothelial carcinoma .
- Informed Consent signed by the subject
Exclusion Criteria:
- Cystoscopic assessment suspicious for MIBC, or prior cross-sectional imaging-such as CT-demonstrating extra bladder extension (e.g., cT3-T4)
- Pregnancy
- MRI contrast agent precaution
- MRI contraindication (including severe claustrophobia and metallic material presence)
- Patients with hip prosthesis (to avoid non diagnostic MRI examination due to metal artifacts)
- Any other condition making the patient unsuitable for the study
- Patient's refusal of transmission of relevant medical conditions found on the medical examinations performed during the study
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Multiparametric Magnetic Resonance Imaging
Participants with suspected bladder cancer will undergo multiparametric magnetic resonance imaging before transurethral resection of bladder tumour. Patients requiring repeat resection according to clinical indications will undergo a second magnetic resonance imaging examination approximately 3-4 weeks after the initial resection. Imaging findings will be compared with histopathological results to assess diagnostic performance.
Diagnostic Test: Multiparametric Magnetic Resonance Imaging of the Bladder
Multiparametric Magnetic Resonance Imaging of the Bladder DIAGNOSTIC_TEST
Bladder magnetic resonance imaging performed using a 3T MRI system, including standard VI-RADS sequences and additional optimized sequences. Imaging is performed before initial transurethral resection and, when clinically indicated, before repeat resection. The study evaluates image quality and the diagnostic performance of magnetic resonance imaging for detecting residual bladder tumour and predicting muscle invasion.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Diagnostic Performance
Plazo: Approximately 3-4 weeks after initial transurethral resection, before repeat resection when clinically indicated.
Diagnostic accuracy metrics (sensitivity, specificity, positive predictive value \[PPV\], and negative predictive value \[NPV\]) of mpMRI performed 3-4 weeks after initial TURBT for detecting residual bladder tumour, using histopathology as the reference standard.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- University of Lausanne Hospitals
- Inicio del estudio
- 2026-12 Estimado
- Finalización primaria
- 3 mar 2028 Estimado
- Finalización del estudio
- 31 mar 2028 Estimado
- Primera publicación
- 9 nov 2026 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Diagnostic Performance of Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Bladder Tumour for Prediction of Muscle Invasion and Detection of Residual Tumour in Non-muscle-invasive Bladder Cancer Patients
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026