Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03058614
Status:
WITHDRAWN
Last Update Posted:
2022-06-06
First Post:
2017-02-16
Brief Title:
Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEUS
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 1046 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21DK109433 | NIH | None | httpsreporternihgovquickSearchR21DK109433 |