Status:
WITHDRAWN
Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Infiltrating Bladder Urothelial Carcinoma
Stage II Bladder Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 c...
Detailed Description
PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the efficacy of laparoscopic high-intensity focused ultrasound (HIFU) for the treatment of localized primary bladder cancer. II. To estimate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03238664
Start Date
January 22 2018
End Date
January 22 2020
Last Update
January 2 2018
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