Trial Outcomes & Findings for Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension (NCT NCT03196076)
NCT ID: NCT03196076
Last Updated: 2021-07-21
Results Overview
Lesions will be assessed for change in size, calcification, and septation using Bosniak criteria to determine whether a lesion has progressed, regressed or is stable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 year
Results posted on
2021-07-21
Participant Flow
The controls without interaction were to be patients that declined enrollment who were willing to participate as controls. No participants agreed to participate in this arm.
Participant milestones
| Measure |
Perflutren Lipid Microsphere (Healthy Subjects)
Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.
Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
|
Perflutren Lipid Microsphere (Patients With Kidney Lesions)
Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.
Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
|
Controls: No Interaction
Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
20
|
0
|
|
Overall Study
COMPLETED
|
5
|
20
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension
Baseline characteristics by cohort
| Measure |
Perflutren Lipid Microsphere (Healthy Subjects)
n=5 Participants
Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.
Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
|
Perflutren Lipid Microsphere (Patients With Kidney Lesions)
n=20 Participants
Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.
Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
|
Controls: No Interaction
Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
—
|
20 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
—
|
5 Participants
n=483 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 15 • n=93 Participants
|
58 years
STANDARD_DEVIATION 11 • n=4 Participants
|
—
|
56 years
STANDARD_DEVIATION 12 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
—
|
8 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
—
|
17 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
—
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
—
|
23 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
—
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
—
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
—
|
13 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
—
|
25 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The controls without interaction were to be patients that declined enrollment who were willing to participate as controls. No participants agreed to participate in this arm.
Lesions will be assessed for change in size, calcification, and septation using Bosniak criteria to determine whether a lesion has progressed, regressed or is stable.
Outcome measures
| Measure |
Perflutren Lipid Microsphere (Healthy Subjects)
n=5 Participants
Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.
Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
|
Perflutren Lipid Microsphere (Patients With Kidney Lesions)
n=20 Participants
Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.
Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
|
Controls: No Interaction
Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.
|
|---|---|---|---|
|
Number of Participants With Change in Radiologist's Lesion Evaluation
Stable
|
0 Participants
|
11 Participants
|
—
|
|
Number of Participants With Change in Radiologist's Lesion Evaluation
Progression
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Change in Radiologist's Lesion Evaluation
Regression
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Change in Radiologist's Lesion Evaluation
Unable to assess
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Change in Radiologist's Lesion Evaluation
Not applicable
|
5 Participants
|
5 Participants
|
—
|
Adverse Events
Perflutren Lipid Microsphere (Healthy Subjects)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Perflutren Lipid Microsphere (Patients With Kidney Lesions)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls: No Interaction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Director of Clinical Research Operations, Department of Radiology
University of North Carolina at Chapel Hill
Phone: 919-966-4997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place