OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma (NCT07751796) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma
15 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
Timeframe: At final pathology review, within 4 weeks after radical nephroureterectomy
. 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.