search
Back to results

Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors

Primary Purpose

Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Transitional Cell Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biopsy
High-Intensity Focused Ultrasound Ablation
Laboratory Biomarker Analysis
Radical Cystectomy
Ultrasonography
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infiltrating Bladder Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm A (laparoscopic HIFU, RARC)

    Arm B (RARC)

    Arm 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.

    Patients undergo standard of care RARC.

    Outcomes

    Primary Outcome Measures

    Complete ablation of the targeted lesion in the bladder wall assessed by histopathologic examination and Live/Dead Viability/Cytotoxicity Assay Kit of the resected specimen (Arm A)
    A Clopper-Pearson (exact) 90% confidence interval will be constructed for the probability of a successful HIFU procedure.
    CTC enumeration assessed using quantitative real-time polymerase chain reaction
    The mean number of CTCs in each patient, as well as the difference between the two arms (possibly after log or square root transformation) will be estimated. Importantly the numbers of CTCs captured in the femoral lines will be compared to the numbers captured in the peripheral lines. Means and 90% confidence intervals will be calculated. Changes in CTC enumeration in a group that undergoes HIFU (Arm A) to a group that does not undergo HIFU (Arm B) will be observed.

    Secondary Outcome Measures

    Incidence of adverse events evaluated according to National Cancer Institute Criteria for Adverse Events version 4.0 (Arm A)
    The complication observed in all patents in each arm will be reported and summarized. For Arm A, focus will be on the complications that might be associated with the HIFU procedure; for Arm B, focus will be on the safety of placed a line in the femoral vein.

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    December 28, 2017
    Sponsor
    University of Southern California
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03238664
    Brief Title
    Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No funding
    Study Start Date
    January 22, 2018 (Anticipated)
    Primary Completion Date
    January 22, 2019 (Anticipated)
    Study Completion Date
    January 22, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southern California
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.
    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 the change in the number of expelled circulating tumor cells (CTCs), when comparing HIFU to robot-assisted radical cystectomy (RARC) alone. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity of using laparoscopic HIFU. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo pre-HIFU contrast-enhanced ultrasound (CEUS), standard of care biopsy of the bladder tumor, laparoscopic HIFU, and post-HIFU CEUS. Patients then undergo standard of care RARC. ARM B: Patients undergo standard of care RARC. After completion of study, patients are followed up at 2 weeks and 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Transitional Cell Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A (laparoscopic HIFU, RARC)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Arm B (RARC)
    Arm Type
    Active Comparator
    Arm Description
    Patients undergo standard of care RARC.
    Intervention Type
    Procedure
    Intervention Name(s)
    Biopsy
    Other Intervention Name(s)
    Bx
    Intervention Description
    Undergo biopsy of bladder tumor
    Intervention Type
    Device
    Intervention Name(s)
    High-Intensity Focused Ultrasound Ablation
    Other Intervention Name(s)
    HIFU, high-intensity focused ultrasound therapy
    Intervention Description
    Undergo laparoscopic HIFU
    Intervention Type
    Other
    Intervention Name(s)
    Laboratory Biomarker Analysis
    Intervention Description
    Correlative studies
    Intervention Type
    Procedure
    Intervention Name(s)
    Radical Cystectomy
    Other Intervention Name(s)
    Complete Cystectomy
    Intervention Description
    Undergo RARC
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasonography
    Other Intervention Name(s)
    2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US
    Intervention Description
    Undergo CEUS
    Primary Outcome Measure Information:
    Title
    Complete ablation of the targeted lesion in the bladder wall assessed by histopathologic examination and Live/Dead Viability/Cytotoxicity Assay Kit of the resected specimen (Arm A)
    Description
    A Clopper-Pearson (exact) 90% confidence interval will be constructed for the probability of a successful HIFU procedure.
    Time Frame
    At the day of surgery
    Title
    CTC enumeration assessed using quantitative real-time polymerase chain reaction
    Description
    The mean number of CTCs in each patient, as well as the difference between the two arms (possibly after log or square root transformation) will be estimated. Importantly the numbers of CTCs captured in the femoral lines will be compared to the numbers captured in the peripheral lines. Means and 90% confidence intervals will be calculated. Changes in CTC enumeration in a group that undergoes HIFU (Arm A) to a group that does not undergo HIFU (Arm B) will be observed.
    Time Frame
    Up to 7 days post-surgery
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events evaluated according to National Cancer Institute Criteria for Adverse Events version 4.0 (Arm A)
    Description
    The complication observed in all patents in each arm will be reported and summarized. For Arm A, focus will be on the complications that might be associated with the HIFU procedure; for Arm B, focus will be on the safety of placed a line in the femoral vein.
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Inderbir Gill, MD
    Organizational Affiliation
    University of Southern California
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors

    We'll reach out to this number within 24 hrs