OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma

Starting soon · Not applicable

Conditions studied: Upper Tract Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT07751796

Run by

Yonsei University

People needed

15

Starts

2026-09-01

Expected to finish

2028-06-23

Last updated by the study team

2026-08-07

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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