Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management (CEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058614
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas Chi, MD, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 16, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date April 22, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
Radiation exposure dose [ Time Frame: 6 months following surgery ]
For radiation exposure dose measurement in this study, the investigators will use dose metrics obtained from the Digital Imaging and Communications within the scanners or Picture Arching and Communication system (PACS).
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
Radiation exposure dose [ Time Frame: 6 months following surgery ]
For radiation exposure dose measurement in this study, we will use dose metrics obtained from the Digital Imaging and Communications within the scanners or Picture Arching and Communication system (PACS).
Change History Complete list of historical versions of study NCT03058614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
Rate of adverse clinical events [ Time Frame: 6 months following surgery ]
Defined as postoperative complications and any unplanned surgery related to the patient's kidney stone
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management
Official Title  ICMJE Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
Brief Summary This study will be a randomized controlled study comparing the use of two clinical management strategies in nephrostomy tube management following percutaneous nephrolithotomy (PCNL). The first strategy entails using contrast-enhanced ultrasound (CEUS) to evaluate the renal collecting system (1). This is a new imaging approach applying ultrasound machines with special software in combination with intraluminal ultrasound contrast agent (Lumason) injection, which is an FDA-approved ultrasound contrast agent (2). The second strategy is a nephrostomy tube capping trial combined with low dose non-contrast computed tomography (CT) scan, one of the most frequently utilized clinical management strategies currently used in clinical practice (3).
Detailed Description

This is a multi-center, randomized controlled study comparing the use of CEUS to CT scan plus capping trial immediately following PCNL. A total recruitment target of 1,046 subjects is planned and participants will be randomized into one of the two study arms.

  1. Contrast-enhanced ultrasound (CEUS) arm: On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
  2. Non-contrast CT scan plus capping trial arm: On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.

Subsequently, nephrostomy tubes will be managed based on the results from these studies by the treating surgeon.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following investigational regimen will be used only in the CEUS arm:

Experimental Investigation: Lumason at a 2 mL single dose, repeatable once at the time of imaging as needed.

Subjects will be exposed to the randomization schema for 1 day during which they will undergo one of the two diagnostic imaging pathways. After that imaging study is complete, clinical care will proceed as per norm. Clinical and imaging data will be prospectively collected from the time of initial presentation until 6 months after surgery. The total duration of the study is expected to be 5 years to reach target accrual. Therefore, the investigators anticipate that the total duration of this study will be 4 years and 6 months for patient recruitment with the final 6 months used for collecting follow up data.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized control study
Masking: Double (Care Provider, Investigator)
Masking Description:
The surgical team will be blinded to the randomization outcome of the patient until the day after surgery so as to minimize any bias introduced into their preoperative counseling. After that point, treatment teams will no longer be blinded to randomization.
Primary Purpose: Diagnostic
Condition  ICMJE
  • Ultrasonography
  • Nephrolithiasis
Intervention  ICMJE
  • Drug: CEUS
    In subjects randomized into the CEUS arm, 2 mL of Lumason will be injected as a single dose via a nephrostomy tube at the time of postoperative renal ultrasound, following by 5 mL of normal saline flush. Subjects will be given up to one additional dose injected in the same fashion as indicated during the imaging study to confirm opacification of the ureter.
    Other Name: Contrast-enhanced ultrasound, CEUS nephrostogram
  • Diagnostic Test: Non-contrast CT scan
    The CT scan performed in this study arm is regularly performed to evaluate the kidney and look for residual stones after surgery both at UCSF and around the world. It does not require contrast injection, so risks from contrast allergy or any injection are absent. A low dose protocol will be used, and therefore, subjects will be exposed to a very small amount of ionizing radiation as low as 1-2 mSv if randomized into this arm.
    Other Name: NCCT
  • Diagnostic Test: Capping trial
    Subjects who are randomized into this study arm will undergo both nephrostomy tube capping and a low dose non-contrast CT scan on the first day after surgery. Successfully passing a capping trial is defined as the absence of fever, worsened flank pain, and leakage around the nephrostomy tube within 4 hours after capping the tube.
Study Arms  ICMJE
  • Active Comparator: CEUS arm
    On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
    Intervention: Drug: CEUS
  • Active Comparator: CT scan plus capping trial arm
    On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.
    Interventions:
    • Diagnostic Test: Non-contrast CT scan
    • Diagnostic Test: Capping trial
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
1046
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age of 18 years or older.
  • Renal and/or ureteral stone of any size diagnosed either by ultrasound or CT scan and requiring surgical treatment with percutaneous removal (PCNL).

Exclusion Criteria:

  • A second stage PCNL is planned or expected after surgery, entailing that postoperative tube management is pre-determined.
  • Subjects with serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
  • Subjects with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
  • Pregnancy, which is a contraindication to both CT scan and ultrasound contrast injection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Chi, MD 415-353-2200 tom.chi@ucsf.edu
Contact: Victoria R. Hogue 415-502-2603 Victoria.Hogue@ucsf.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03058614
Other Study ID Numbers  ICMJE 17-21497
R21DK109433 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Chi, MD, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Oregon Health and Science University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Thomas Chi, MD UCSF Department of Urology
PRS Account University of California, San Francisco
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP