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

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03058614

Collaborator

Oregon Health and Science University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Arms

58.1

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ultrasonography Nephrolithiasis	Drug: CEUS Diagnostic Test: Non-contrast CT scan Diagnostic Test: Capping trial	Phase 2

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control studyRandomized 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.

Primary Purpose:

Diagnostic

Official Title:

Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient

Anticipated Study Start Date :

Jun 30, 2017

Actual Primary Completion Date :

May 2, 2022

Actual Study Completion Date :

May 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: CEUS 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 Names: 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 Names: 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.

Arm

Intervention/Treatment

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.

Drug: CEUS

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 Names:

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Radiation exposure dose [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).

Secondary Outcome Measures

Rate of adverse clinical events [6 months following surgery]
Defined as postoperative complications and any unplanned surgery related to the patient's kidney stone

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Francisco
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Thomas Chi, MD, UCSF Department of Urology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Thomas Chi, MD, Assistant Professor, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT03058614

Other Study ID Numbers:

17-21497
R21DK109433

First Posted:

Feb 23, 2017

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Chi, MD, Assistant Professor, University of California, San Francisco

Contrast-enhanced ultrasound

Percutaneous nephrolithotomy

Additional relevant MeSH terms:

Kidney Calculi

Nephrolithiasis

Study Results

No Results Posted as of Jun 6, 2022