Clinical trial · Interventional
Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors
Robot-Assisted Laparoscopic HIFU (High-Intensity Focused Ultrasound) of the Bladder Wall for Thermal Ablation of Muscle Invasive Cells of Bladder Tumors: Corroborating With Robot-Assisted Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
This randomized pilot trial studies how well robot-assisted laparoscopic high-intensity focused ultrasound works compared to robot-assisted radical cystectomy for thermal ablation of muscle invasive cells in patients with bladder tumors. Laparoscopic high-intensity focused ultrasound uses high frequency sound waves to deliver a strong beam to a specific part of the tumor and may lower the number of tumor cells released into the blood stream compared to radical cystectomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infiltrating Bladder Urothelial Carcinoma | Invasive Bladder Urothelial Carcinoma | ALIAS | 0.90 |
| Stage II Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| High-Intensity Focused Ultrasound Ablation | Device | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Radical Cystectomy | Procedure | — | UNRESOLVED |
| Ultrasonography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (laparoscopic HIFU, RARC)
- description
- Patients undergo pre-HIFU CEUS, standard of care biopsy of the bladder tumor, laparoscopic HIFU, and post-HIFU CEUS. Patients then undergo standard of care RARC.
- interventionNames
- Procedure: Biopsy
- Device: High-Intensity Focused Ultrasound Ablation
- Other: Laboratory Biomarker Analysis
- Procedure: Radical Cystectomy
- Device: Ultrasonography
- type
- ACTIVE_COMPARATOR
- label
- Arm B (RARC)
- description
- Patients undergo standard of care RARC.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Procedure: Radical Cystectomy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must meet all inclusion and exclusion criteria * Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell carcinoma on pre-operative histology (i.e. biopsy or transurethral resection of bladder tumor \[TURBT\]). * Presence of a single bladder tumor lesion * Patients are scheduled to undergo RARC at our institution * Subjects must have given written informed consent to agree to participate * Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery; chemotherapy can be within 70 days of operation * Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations * Pre-operative computed tomography (CT)/magnetic resonance imaging (MRI) abdomen and pelvis within 90 days * Absolute neutrophil count (ANC) \>= 1500 mm\^-3 * Platelet count \>= 100,000 mm\^-3 * Hemoglobin \>= 10 g/dl * Prothrombin time (PT) =\< 1.5 times upper limit of laboratory normal (ULN) * Activated partial thromboplastin time =\< 1.5 times ULN * Total bilirubin \< 1.5 times ULN * Aspartate aminotransferase (AST) =\< 3 times ULN * Alkaline phosphatase \< 2 times ULN, unless arising from bone Exclusion Criteria: * Subjects deemed unsuitable candidates and not medically optimized for RARC * Subjects with tumors lying \< 1 cm from sensitive structures such as the ureter, prostate or adjacent bowel * Patients with presence of multiple bladder lesions * Subjects on concurrent anticoagulant, or immunosuppressive medication * Patients with pre-operative histologic confirmation of a bladder lesion other than transitional cell carcinoma * Subjects on anti-cancer medication whether biologic or pharmaceutical * Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment) * Subjects assessed by consultant anesthetist as unsuitable for general anesthetic * Absolute contraindications: venous injury at the level of the femoral veins or proximally; known or suspected thrombosis of the femoral or iliac veins on the proposed side of venous cannulation, ambulatory patient * Relative contraindications: presence of bleeding disorders; distortion of anatomy due to local injury or deformity; previous long-term venous catheterization; history of vasculitis; previous injection of sclerosis agents; previous radiation therapy
References
Publications (0)
Data not yet available