Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma

3 augustus 2026 bijgewerkt door: Yonsei University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

15

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Won Sik Ham, Professor
  • Telefoonnummer: +82-2-2228-2310
  • E-mail: uroham@yuhs.ac

Studie Contact Back-up

  • Naam: Jee Soo Park, Study Contact
  • Telefoonnummer: +82-2-2228-2310
  • E-mail: sampark@yuhs.ac

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: IVUS Imaging Before Radical Nephroureterectomy
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.
Apparaat: OptiCross HD Coronary Imaging Catheter
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Concordance Between IVUS-Based T Stage and Final Pathologic T Stage
Tijdsspanne: 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.
At final pathology review, within 4 weeks after radical nephroureterectomy

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Visualization of the Three Upper Urinary Tract Wall Layers
Tijdsspanne: During blinded image review, within 4 weeks after surgery
Proportion of evaluable examinations in which the urothelium, muscularis, and adventitia are distinguishable.
During blinded image review, within 4 weeks after surgery
Clarity of Lesion-Boundary Visualization
Tijdsspanne: During blinded image review, within 4 weeks after surgery
Lesion boundary is rated as clear, partially clear, or unclear by each blinded reviewer.
During blinded image review, within 4 weeks after surgery
Technical Success of IVUS Catheter Placement and Image Acquisition
Tijdsspanne: During the intraoperative IVUS procedure
Proportion of attempted procedures in which the catheter reaches the target lesion and diagnostically interpretable images are acquired.
During the intraoperative IVUS procedure
Incidence of IVUS-Related Adverse Events
Tijdsspanne: From IVUS catheter insertion through the final follow-up, up to 3 months after surgery
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.
From IVUS catheter insertion through the final follow-up, up to 3 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yonsei University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

23 juni 2028

Studieregistratiedata

Eerst ingediend

3 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 augustus 2026

Eerst geplaatst (Werkelijk)

7 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 1-2026-0024

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren