Trial Outcomes & Findings for Contrast-enhanced Ultrasound of the Kidney (NCT NCT02684435)

Last Updated: 2019-09-26

Results Overview

Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Baseline, 1 year

Results posted on

2019-09-26

Participant Flow

Unit of analysis: lesions

Participant milestones

Participant milestones
Measure	Perflutren Lipid Microsphere Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Perflutren lipid microsphere: Dosing per approved package label
Overall Study STARTED	63 64
Overall Study COMPLETED	63 64
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contrast-enhanced Ultrasound of the Kidney

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perflutren Lipid Microsphere n=63 Participants Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Perflutren lipid microsphere: Dosing per approved package label
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 year

Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable.

Outcome measures

Outcome measures
Measure	Perflutren Lipid Microsphere n=64 lesions Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Perflutren lipid microsphere: Dosing per approved package label
Number of Lesions With a Change in Radiologist's Evaluation	24 lesions

PRIMARY outcome

Timeframe: Baseline, 1 year

PRELIMINARY RESULTS of sensitivity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard

Outcome measures

Outcome measures
Measure	Perflutren Lipid Microsphere n=63 Participants Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Perflutren lipid microsphere: Dosing per approved package label
Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy	75 percentage of positive scans

PRIMARY outcome

Timeframe: Baseline, 1 year

PRELIMINARY RESULTS of specificity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard

Outcome measures

Outcome measures
Measure	Perflutren Lipid Microsphere n=63 Participants Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Perflutren lipid microsphere: Dosing per approved package label
Specificity of Qualitative Interpretations of CEUS	71 percentage of negative scans

SECONDARY outcome

Timeframe: Baseline, 1 Year

Population: Quantitative analysis unable to be conducted on cystic lesions and required solid portions, so data was not collected

Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 Year

Population: Quantitative analysis unable to be conducted on cystic lesions and required solid portions, so data was not collected

Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard

Outcome measures

Outcome data not reported

Adverse Events

Perflutren Lipid Microsphere

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Perflutren Lipid Microsphere n=63 participants at risk Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Perflutren lipid microsphere: Dosing per approved package label
Musculoskeletal and connective tissue disorders Bilateral back pain that resolved by the time of discharge.	1.6% 1/63 • Number of events 1 • Up to 30 minutes post imaging at baseline visit

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