Infiltrating Bladder Urothelial CarcinomaNCT03238664
Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors
A study testing Biopsy, High-Intensity Focused Ultrasound Ablation and Laboratory Biomarker Analysis in people with Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, run by University of Southern California.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Transitional Cell Carcinoma
- What is being tested?
- Biopsy, High-Intensity Focused Ultrasound Ablation and Laboratory Biomarker Analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2018to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Transitional Cell Carcinoma
- Being tested
- Biopsy, High-Intensity Focused Ultrasound Ablation, Laboratory Biomarker Analysis, Radical Cystectomy, Ultrasonography
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo biopsy of bladder tumor
High-Intensity Focused Ultrasound AblationDevice
Also called HIFU, high-intensity focused ultrasound therapy
Undergo laparoscopic HIFU
Laboratory Biomarker AnalysisOther
Correlative studies
Radical CystectomyProcedure or surgery
Also called Complete Cystectomy
Undergo RARC
UltrasonographyDevice
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound
Undergo CEUS
| Study group | Role | What they receive |
|---|---|---|
| Arm A (laparoscopic HIFU, RARC) | Experimental | 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. Receives: Procedure: Biopsy; Device: High-Intensity Focused Ultrasound Ablation; Other: Laboratory Biomarker Analysis; Procedure: Radical Cystectomy; Device: Ultrasonography |
| Arm B (RARC) | Active comparator | Patients undergo standard of care RARC. Receives: Other: Laboratory Biomarker Analysis; Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the day of surgery
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.
Measured: Up to 7 days post-surgery
Secondary outcomes (1)
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start22 Jan 2018 (estimated)
- Primary completion22 Jan 2019 (estimated)
- Study completion22 Jan 2020 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infiltrating Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Inderbir Gill, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238664
- Sponsor's protocol ID
- 4B-15-6
- Other IDs
- NCI-2017-00626, 4B-15-6, P30CA014089
- Status last verified
- Dec 2017
- First submitted
- 31 Jul 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03238664
- Acronym / sponsor ID
- 4B-15-6
- Conditions
- Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Transitional Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jan 2018 (estimated)
- Primary completion
- 22 Jan 2019 (estimated)
- Study completion
- 22 Jan 2020 (estimated)
- First posted
- 3 Aug 2017 (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.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (laparoscopic HIFU, RARC) | Experimental | Procedure: Biopsy, Device: High-Intensity Focused Ultrasound Ablation, Other: Laboratory Biomarker Analysis, Procedure: Radical Cystectomy, Device: UltrasonographyPatients 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 B (RARC) | Active comparator | Other: Laboratory Biomarker Analysis, Procedure: Radical CystectomyPatients undergo standard of care RARC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| BiopsyAlso: BxUndergo biopsy of bladder tumor | Procedure or surgery | Arm A (laparoscopic HIFU, RARC) |
| High-Intensity Focused Ultrasound AblationAlso: HIFU, high-intensity focused ultrasound therapyUndergo laparoscopic HIFU | Device | Arm A (laparoscopic HIFU, RARC) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (laparoscopic HIFU, RARC), Arm B (RARC) |
| Radical CystectomyAlso: Complete CystectomyUndergo RARC | Procedure or surgery | Arm A (laparoscopic HIFU, RARC), Arm B (RARC) |
| UltrasonographyAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasoundUndergo CEUS | Device | Arm A (laparoscopic HIFU, RARC) |
Primary outcome
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)
Time frame: At the day of surgery
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
Time frame: Up to 7 days post-surgery
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.
1 secondary outcome
Incidence of adverse events evaluated according to National Cancer Institute Criteria for Adverse Events version 4.0 (Arm A)
Time frame: Up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
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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. This study is not recruiting at the moment.
Inderbir Gill, MD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, High-Intensity Focused Ultrasound Ablation and Laboratory Biomarker Analysis in people with Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, run by University of Southern California.
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 16 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Jan 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: At the day of surgery). The study lists 2 primary outcomes in all. 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 2 Jan 2018.