Clinical trial NCT03058614: Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management
Official title: Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ultrasonography
Nephrolithiasis
Keywords: Contrast-enhanced ultrasound
Percutaneous nephrolithotomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control study
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Radiation exposure dose
timeFrame: 6 months following surgery
Secondary outcomes:
measure: Rate of adverse clinical events
timeFrame: 6 months following surgery
Other outcomes:
Locations:
Study officials:
affiliation: UCSF Department of Urology
name: Thomas Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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
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.