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

Primary Purpose

Ultrasonography, Nephrolithiasis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CEUS
Non-contrast CT scan
Capping trial
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ultrasonography focused on measuring Contrast-enhanced ultrasound, Percutaneous nephrolithotomy

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    CEUS arm

    CT scan plus capping trial arm

    Arm Description

    On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.

    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.

    Outcomes

    Primary Outcome Measures

    Radiation exposure dose
    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).

    Secondary Outcome Measures

    Rate of adverse clinical events
    Defined as postoperative complications and any unplanned surgery related to the patient's kidney stone

    Full Information

    First Posted
    February 16, 2017
    Last Updated
    June 1, 2022
    Sponsor
    University of California, San Francisco
    Collaborators
    Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03058614
    Brief Title
    Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management
    Acronym
    CEUS
    Official Title
    Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The research team submitted grants over the course of several years to gain funds to support this research but were unsuccessful in securing the funds. The research team will now focus on other funded studies.
    Study Start Date
    June 30, 2017 (Anticipated)
    Primary Completion Date
    May 2, 2022 (Actual)
    Study Completion Date
    May 2, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ultrasonography, Nephrolithiasis
    Keywords
    Contrast-enhanced ultrasound, Percutaneous nephrolithotomy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized control study
    Masking
    Care ProviderInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CEUS arm
    Arm Type
    Active Comparator
    Arm Description
    On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
    Arm Title
    CT scan plus capping trial arm
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    CEUS
    Other Intervention Name(s)
    Contrast-enhanced ultrasound, CEUS nephrostogram
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Non-contrast CT scan
    Other Intervention Name(s)
    NCCT
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Capping trial
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Radiation exposure dose
    Description
    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).
    Time Frame
    6 months following surgery
    Secondary Outcome Measure Information:
    Title
    Rate of adverse clinical events
    Description
    Defined as postoperative complications and any unplanned surgery related to the patient's kidney stone
    Time Frame
    6 months following surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Chi, MD
    Organizational Affiliation
    UCSF Department of Urology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28234551
    Citation
    Chi T, Usawachintachit M, Mongan J, Kohi MP, Taylor A, Jha P, Chang HC, Stoller M, Goldstein R, Weinstein S. Feasibility of Antegrade Contrast-enhanced US Nephrostograms to Evaluate Ureteral Patency. Radiology. 2017 Apr;283(1):273-279. doi: 10.1148/radiol.2016160959. Epub 2016 Oct 19.
    Results Reference
    background
    Citation
    Lumason: Prescribing Information [Internet]. [cited 2017 Jan 21]. Available from: http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-information
    Results Reference
    background
    PubMed Identifier
    23590513
    Citation
    Sountoulides P, Metaxa L, Cindolo L. Is computed tomography mandatory for the detection of residual stone fragments after percutaneous nephrolithotomy? J Endourol. 2013 Nov;27(11):1341-8. doi: 10.1089/end.2012.0253. Epub 2013 Jul 9.
    Results Reference
    background

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

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