Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management (CEUS)
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|ClinicalTrials.gov Identifier: NCT03058614|
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ultrasonography Nephrolithiasis||Drug: CEUS Diagnostic Test: Non-contrast CT scan Diagnostic Test: Capping trial||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1046 participants|
|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.|
|Official Title:||Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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.
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
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.
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.
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058614
|Contact: Thomas Chi, MDfirstname.lastname@example.org|
|Contact: Victoria R. Hogue||415-502-2603||Victoria.Hogue@ucsf.edu|
|Principal Investigator:||Thomas Chi, MD||UCSF Department of Urology|