NCT07751796Not yet recruiting
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 · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 3 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Yonsei University
- Diseases
- Bladder cancer
- NCT number
- NCT07751796
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Sept 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active urinary tract infection or uncontrolled coagulopathy that increases the risk of ureteroscopic manipulation.
- Any systemic condition or other circumstance judged by the investigator to make participation inappropriate or to interfere with interpretation of the study results.
Other
- 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.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.