drugset / Trial / NCT03058614
Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management
Phase 2
Withdrawn
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabOregon Health and Science University · collab
RandomizedParallel-groupDouble-blindDiagnostic
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).
Timeline
- Start
- 2017-06-30
- Primary completion
- 2022-05-02
- Completion
- 2022-05-02
Publications
- Background 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.
- Background 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
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lumason | Diagnostic / imaging agent | 2 ml | Other |