Upper Tract Urothelial CarcinomaNCT07751796
OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma
A study testing OptiCross HD Coronary Imaging Catheter in people with Upper Tract Urothelial Carcinoma, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- OptiCross HD Coronary Imaging Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 23 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
This is a prospective, single-center, single-arm, investigator-initiated exploratory device study conducted at Severance Hospital. Eligible participants are adults with UTUC diagnosed or strongly suspected on imaging and/or ureteroscopic biopsy for whom RNU has already been selected as the standard treatment. Participation does not change the planned operation.
After written informed consent and confirmation of eligibility, the OptiCross HD 60-MHz IVUS catheter is advanced over a 0.014-inch guidewire to the renal pelvis or ureteral lesion under endoscopic and fluoroscopic guidance during general anesthesia. A short manual or automated pullback is performed to acquire cross-sectional images of the lesion and adjacent upper urinary tract wall. The catheter is removed immediately after imaging, and the planned RNU is then performed.
IVUS images are reviewed independently by three specialists who did not participate in the procedure and are blinded to preoperative clinical information and final pathology. Each reviewer assigns an IVUS-based T stage and records whether the urothelium, muscularis, and adventitia can be distinguished, whether the lesion boundary is visualized, and whether image quality is diagnostically adequate. A majority interpretation from at least two of the three reviewers is used for the main concordance analysis.
The primary analysis compares IVUS-based T stage with the final pathologic pT stage from the resected specimen. Secondary analyses include technical success, visualization of the three wall layers, lesion-boundary clarity, inter-reviewer agreement, and device- or procedure-related adverse events. Safety is assessed during the procedure, during hospitalization, at approximately 4 weeks, and at the final follow-up approximately 3 months after surgery.
- Conditions
- Upper Tract Urothelial Carcinoma
- Being tested
- OptiCross HD Coronary Imaging Catheter
- Keywords
- UTUC, intravascular ultrasound, IVUS, intraluminal ultrasound; ureter, renal pelvis, invasion depth, T stage, radical nephroureterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiCross HD Coronary Imaging CatheterDevice
A 60-MHz OptiCross HD IVUS catheter is advanced over a 0.014-inch guidewire to the upper urinary tract lesion during the planned operative procedure. Cross-sectional images are acquired by manual or automated pullback over the lesion, after which the catheter is removed and the planned radical nephroureterectomy proceeds. The IVUS result is not used to alter treatment.
| Study group | Role | What they receive |
|---|---|---|
| IVUS Imaging Before Radical Nephroureterectomy | Experimental | 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. Receives: Device: OptiCross HD Coronary Imaging Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
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.
Measured: At final pathology review, within 4 weeks after radical nephroureterectomy
Secondary outcomes (4)
Visualization of the Three Upper Urinary Tract Wall Layers
Proportion of evaluable examinations in which the urothelium, muscularis, and adventitia are distinguishable.
Measured: During blinded image review, within 4 weeks after surgery
Clarity of Lesion-Boundary Visualization
Lesion boundary is rated as clear, partially clear, or unclear by each blinded reviewer.
Measured: During blinded image review, within 4 weeks after surgery
Technical Success of IVUS Catheter Placement and Image Acquisition
Proportion of attempted procedures in which the catheter reaches the target lesion and diagnostically interpretable images are acquired.
Measured: During the intraoperative IVUS procedure
Incidence of IVUS-Related Adverse Events
Number and proportion of participants with device- or procedure-related adverse events, including hematuria, pain, mucosal injury, perforation, catheter malfunction, or other complications, summarized by severity and relatedness.
Measured: From IVUS catheter insertion through the final follow-up, up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion23 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive the same IVUS imaging procedure immediately before the planned radical nephroureterectomy.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751796
- Sponsor's protocol ID
- 1-2026-0024
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07751796
- Acronym / sponsor ID
- 1-2026-0024
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- UTUC, intravascular ultrasound, IVUS, intraluminal ultrasound; ureter, renal pelvis, invasion depth, T stage, radical nephroureterectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 23 Jun 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center, single-arm, investigator-initiated exploratory device study conducted at Severance Hospital. Eligible participants are adults with UTUC diagnosed or strongly suspected on imaging and/or ureteroscopic biopsy for whom RNU has already been selected as the standard treatment. Participation does not change the planned operation.
After written informed consent and confirmation of eligibility, the OptiCross HD 60-MHz IVUS catheter is advanced over a 0.014-inch guidewire to the renal pelvis or ureteral lesion under endoscopic and fluoroscopic guidance during general anesthesia. A short manual or automated pullback is performed to acquire cross-sectional images of the lesion and adjacent upper urinary tract wall. The catheter is removed immediately after imaging, and the planned RNU is then performed.
IVUS images are reviewed independently by three specialists who did not participate in the procedure and are blinded to preoperative clinical information and final pathology. Each reviewer assigns an IVUS-based T stage and records whether the urothelium, muscularis, and adventitia can be distinguished, whether the lesion boundary is visualized, and whether image quality is diagnostically adequate. A majority interpretation from at least two of the three reviewers is used for the main concordance analysis.
The primary analysis compares IVUS-based T stage with the final pathologic pT stage from the resected specimen. Secondary analyses include technical success, visualization of the three wall layers, lesion-boundary clarity, inter-reviewer agreement, and device- or procedure-related adverse events. Safety is assessed during the procedure, during hospitalization, at approximately 4 weeks, and at the final follow-up approximately 3 months after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the same IVUS imaging procedure immediately before the planned radical nephroureterectomy.
| Arm | Type | Receives |
|---|---|---|
| IVUS Imaging Before Radical Nephroureterectomy | Experimental | Device: OptiCross HD Coronary Imaging CatheterParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptiCross HD Coronary Imaging CatheterA 60-MHz OptiCross HD IVUS catheter is advanced over a 0.014-inch guidewire to the upper urinary tract lesion during the planned operative procedure. Cross-sectional images are acquired by manual or automated pullback over the lesion, after which the catheter is removed and the planned radical nephroureterectomy proceeds. The IVUS result is not used to alter treatment. | Device | IVUS Imaging Before Radical Nephroureterectomy |
Primary outcome
Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
Time frame: At final pathology review, within 4 weeks after radical nephroureterectomy
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.
4 secondary outcomes
Visualization of the Three Upper Urinary Tract Wall Layers
Time frame: During blinded image review, within 4 weeks after surgery
Clarity of Lesion-Boundary Visualization
Time frame: During blinded image review, within 4 weeks after surgery
Technical Success of IVUS Catheter Placement and Image Acquisition
Time frame: During the intraoperative IVUS procedure
Incidence of IVUS-Related Adverse Events
Time frame: From IVUS catheter insertion through the final follow-up, up to 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing OptiCross HD Coronary Imaging Catheter in people with Upper Tract Urothelial Carcinoma, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Won Sik Ham, Professor (+82-2-2228-2310, uroham@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance Between IVUS-Based T Stage and Final Pathologic T Stage (time frame: At final pathology review, within 4 weeks after radical nephroureterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.