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Can a tiny ultrasound probe see how deep a urinary tract tumor goes?

NCT ID NCT07751796

Diagnosis Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether a specialized ultrasound catheter, normally used in heart arteries, can be safely threaded into the upper urinary tract to measure how deeply a tumor has invaded the wall. Fifteen adults with upper tract urothelial carcinoma who are already scheduled for surgical removal of the kidney and ureter will receive one ultrasound exam right before surgery. The ultrasound images will be compared with the actual tumor depth found in the removed tissue to see if they match. The ultrasound result will not change the planned surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OptiCross HD intravascular ultrasound catheter
What this could lead to
If successful, this could improve how doctors determine the depth of upper tract urothelial carcinoma before surgery, potentially guiding more precise treatment decisions.
What could go wrong
This is a small exploratory study with only 15 participants, and the ultrasound readings may not match the actual tumor depth found after surgery. There is also a risk of complications from inserting the catheter into the urinary tract.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

renal pelvis/ureter urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Upper tract urothelial carcinoma

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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