OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma
A Prospective, Single-center, Single-arm, Investigator-Initiated Exploratory Clinical Trial to Evaluate the Lesion Invasion Depth Using Intraluminal Images of a Percutaneous Catheter for Intravascular Ultrasound (OptiCross™ HD) Compared With Pathological Results in Patients With Upper Tract Urothelial Carcinoma
Upper tract urothelial carcinoma (UTUC) is difficult to stage accurately because cross-sectional imaging and ureteroscopic biopsy may not reliably demonstrate muscular or periureteral invasion. This exploratory study evaluates whether a 60-MHz OptiCross HD intravascular ultrasound (IVUS) catheter can be safely introduced into the renal pelvis or ureter during planned surgery and provide intraluminal images that correspond to the final pathologic T stage.
Fifteen adults with suspected or confirmed UTUC who are already scheduled for radical nephroureterectomy (RNU) will undergo one IVUS examination immediately before surgery. The IVUS result will not alter the planned treatment. Three independent reviewers who are blinded to clinical and pathologic information will assess invasion depth and image quality. IVUS-based T stage will be compared with postoperative pathology. Technical success, visualization of ureteral wall layers and lesion boundaries, and adverse events will also be evaluated through 3 months after surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-center, single-arm, investigator-initiated exploratory device study conducted at Severance Hospital. Eligible participants are adults with UTUC diagnosed or strongly suspected on imaging and/or ureteroscopic biopsy for whom RNU has already been selected as the standard treatment. Participation does not change the planned operation.
After written informed consent and confirmation of eligibility, the OptiCross HD 60-MHz IVUS catheter is advanced over a 0.014-inch guidewire to the renal pelvis or ureteral lesion under endoscopic and fluoroscopic guidance during general anesthesia. A short manual or automated pullback is performed to acquire cross-sectional images of the lesion and adjacent upper urinary tract wall. The catheter is removed immediately after imaging, and the planned RNU is then performed.
IVUS images are reviewed independently by three specialists who did not participate in the procedure and are blinded to preoperative clinical information and final pathology. Each reviewer assigns an IVUS-based T stage and records whether the urothelium, muscularis, and adventitia can be distinguished, whether the lesion boundary is visualized, and whether image quality is diagnostically adequate. A majority interpretation from at least two of the three reviewers is used for the main concordance analysis.
The primary analysis compares IVUS-based T stage with the final pathologic pT stage from the resected specimen. Secondary analyses include technical success, visualization of the three wall layers, lesion-boundary clarity, inter-reviewer agreement, and device- or procedure-related adverse events. Safety is assessed during the procedure, during hospitalization, at approximately 4 weeks, and at the final follow-up approximately 3 months after surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Won Sik Ham, Professor
- Número de teléfono: +82-2-2228-2310
- Correo electrónico: uroham@yuhs.ac
Copia de seguridad de contactos de estudio
- Nombre: Jee Soo Park, Study Contact
- Número de teléfono: +82-2-2228-2310
- Correo electrónico: sampark@yuhs.ac
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 19 years or older, male or female.
- UTUC diagnosed or strongly suspected based on preoperative CT or MRI and ureteroscopic biopsy.
- A lesion identified on imaging for which the depth of invasion is difficult to determine and surgery is considered necessary.
- RNU has been definitively selected by the treating physician, allowing direct comparison of IVUS findings with postoperative pathology.
- Upper urinary tract anatomy permits safe passage of the 3.1-F IVUS catheter to the lesion.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Ureteral stricture, severe angulation, congenital anomaly, or other anatomy that prevents safe catheter advancement.
- Definite distant metastasis (M1) or adjacent-organ invasion (T4) on imaging.
- Active urinary tract infection or uncontrolled coagulopathy that increases the risk of ureteroscopic manipulation.
- Pregnancy or breastfeeding.
- Any systemic condition or other circumstance judged by the investigator to make participation inappropriate or to interfere with interpretation of the study results.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: IVUS Imaging Before Radical Nephroureterectomy
Participants undergo a single intraoperative OptiCross HD IVUS examination of the renal pelvis or ureteral lesion immediately before the already-planned radical nephroureterectomy.
IVUS findings are not used to change treatment.
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A 60-MHz OptiCross HD IVUS catheter is advanced over a 0.014-inch guidewire to the upper urinary tract lesion during the planned operative procedure.
Cross-sectional images are acquired by manual or automated pullback over the lesion, after which the catheter is removed and the planned radical nephroureterectomy proceeds.
The IVUS result is not used to alter treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
Periodo de tiempo: At final pathology review, within 4 weeks after radical nephroureterectomy
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The IVUS-based T stage (Ta, T1, T2, or T3 or higher) assigned by each blinded reviewer and the majority interpretation from at least 2 of 3 reviewers will be compared with the final surgical pathology pT stage.
Concordance rate will be calculated as the number of evaluable participants with matching IVUS and pathology stages divided by the total number of evaluable participants, multiplied by 100.
Agreement will also be explored using kappa statistics.
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At final pathology review, within 4 weeks after radical nephroureterectomy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visualization of the Three Upper Urinary Tract Wall Layers
Periodo de tiempo: During blinded image review, within 4 weeks after surgery
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Proportion of evaluable examinations in which the urothelium, muscularis, and adventitia are distinguishable.
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During blinded image review, within 4 weeks after surgery
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Clarity of Lesion-Boundary Visualization
Periodo de tiempo: During blinded image review, within 4 weeks after surgery
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Lesion boundary is rated as clear, partially clear, or unclear by each blinded reviewer.
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During blinded image review, within 4 weeks after surgery
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Technical Success of IVUS Catheter Placement and Image Acquisition
Periodo de tiempo: During the intraoperative IVUS procedure
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Proportion of attempted procedures in which the catheter reaches the target lesion and diagnostically interpretable images are acquired.
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During the intraoperative IVUS procedure
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Incidence of IVUS-Related Adverse Events
Periodo de tiempo: From IVUS catheter insertion through the final follow-up, up to 3 months after surgery
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Number and proportion of participants with device- or procedure-related adverse events, including hematuria, pain, mucosal injury, perforation, catheter malfunction, or other complications, summarized by severity and relatedness.
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From IVUS catheter insertion through the final follow-up, up to 3 months after surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1-2026-0024
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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