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UltrasonographyPhase 2CEUSNCT03058614

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

A Phase 2 study testing CEUS, Non-contrast CT scan and Capping trial in people with Ultrasonography and Nephrolithiasis, run by University of California, San Francisco.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ultrasonography, Nephrolithiasis
What is being tested?
CEUS, Non-contrast CT scan and Capping trial
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jun 2017to 2 May 2022
Phase
Phase 2
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

  • 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).

Who cannot join

  • 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.

About this study

Official title: Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient

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).

Read the 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.

Being tested
CEUS, Non-contrast CT scan, Capping trial
Keywords
Contrast-enhanced ultrasound, Percutaneous nephrolithotomy
Medical subject headings
Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEUSDrug

    Also called Contrast-enhanced ultrasound, CEUS nephrostogram

    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.

  • Non-contrast CT scanDiagnostic test

    Also called NCCT

    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.

  • Capping trialDiagnostic test

    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 groups in NCT03058614
Study groupRoleWhat they receive
CEUS armActive comparatorOn postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
Receives: Drug: CEUS
CT scan plus capping trial armActive comparatorOn 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.
Receives: Diagnostic Test: Non-contrast CT scan; Diagnostic Test: Capping trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months following surgery

Secondary outcomes (1)

  1. Rate of adverse clinical events

    Defined as postoperative complications and any unplanned surgery related to the patient's kidney stone

    Measured: 6 months following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start30 Jun 2017 (estimated)
  3. Primary completion2 May 2022
  4. Study completion2 May 2022

Why it 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.

Resources

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 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control study
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03058614
Sponsor's protocol ID
17-21497
Other IDs
R21DK109433
Acronym
CEUS
Status last verified
Jun 2022
First submitted
16 Feb 2017
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28234551

  • 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

  • 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.

    PubMed 23590513

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CEUS, Non-contrast CT scan and Capping trial in people with Ultrasonography and Nephrolithiasis, run by University of California, San Francisco.

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 2 inclusion and 4 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 6 Jun 2022. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Radiation exposure dose (time frame: 6 months following surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058614, which also lists 3 linked publications.

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 6 Jun 2022.

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