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.
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.
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.
Single group
OptiCross HD Coronary Imaging Catheter
DeviceA 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.
Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
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.
Visualization of the Three Upper Urinary Tract Wall Layers
Proportion of evaluable examinations in which the urothelium, muscularis, and adventitia are distinguishable.
Clarity of Lesion-Boundary Visualization
Lesion boundary is rated as clear, partially clear, or unclear by each blinded reviewer.
Technical Success of IVUS Catheter Placement and Image Acquisition
Proportion of attempted procedures in which the catheter reaches the target lesion and diagnostically interpretable images are acquired.
Incidence of IVUS-Related Adverse Events
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
