Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Tract Urothelial Carcinoma | Renal Pelvis and Ureter Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OptiCross HD Coronary Imaging Catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IVUS Imaging Before Radical Nephroureterectomy
- description
- 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.
- interventionNames
- Device: OptiCross HD Coronary Imaging Catheter
Primary outcomes (1)
- measure
- Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
- timeFrame
- At final pathology review, within 4 weeks after radical nephroureterectomy
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults aged 19 years or older, male or female. 2. UTUC diagnosed or strongly suspected based on preoperative CT or MRI and ureteroscopic biopsy. 3. A lesion identified on imaging for which the depth of invasion is difficult to determine and surgery is considered necessary. 4. RNU has been definitively selected by the treating physician, allowing direct comparison of IVUS findings with postoperative pathology. 5. Upper urinary tract anatomy permits safe passage of the 3.1-F IVUS catheter to the lesion. 6. Ability and willingness to provide written informed consent. Exclusion Criteria: 1. Ureteral stricture, severe angulation, congenital anomaly, or other anatomy that prevents safe catheter advancement. 2. Definite distant metastasis (M1) or adjacent-organ invasion (T4) on imaging. 3. Active urinary tract infection or uncontrolled coagulopathy that increases the risk of ureteroscopic manipulation. 4. Pregnancy or breastfeeding. 5. Any systemic condition or other circumstance judged by the investigator to make participation inappropriate or to interfere with interpretation of the study results.
References
Publications (0)
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