Trial Outcomes & Findings for IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys? (NCT NCT02625428)

Results Overview

Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

1 year

Results posted on

2020-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	For Cause For cause biopsy to evaluate a recent rise in serum creatinine. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.	Surveillance Surveillance biopsy done after transplant mostly looking for subclinical rejection. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	For Cause n=20 Participants For cause biopsy to evaluate a recent rise in serum creatinine. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.	Surveillance n=20 Participants Surveillance biopsy done after transplant mostly looking for subclinical rejection. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.	Total n=40 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 13.4 • n=20 Participants	50.8 years STANDARD_DEVIATION 14.1 • n=20 Participants	52.6 years STANDARD_DEVIATION 13.7 • n=40 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	4 Participants n=20 Participants	12 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=20 Participants	16 Participants n=20 Participants	28 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants
Serum Creatinine	3.3 mg/dL STANDARD_DEVIATION 1.9 • n=20 Participants	1.5 mg/dL STANDARD_DEVIATION 0.4 • n=20 Participants	2.4 mg/dL STANDARD_DEVIATION 1.6 • n=40 Participants

PRIMARY outcome

Timeframe: 1 year

Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist

Outcome measures

Outcome measures
Measure	For Cause n=20 Participants For cause biopsy to evaluate a recent rise in serum creatinine. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.	Surveillance n=20 Participants Surveillance biopsy done after transplant mostly looking for subclinical rejection. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.
Abnormal Biopsy	10 Participants	7 Participants

SECONDARY outcome

Timeframe: 1 year

Population: This outcome measure was not evaluated or analyzed as all subjects received multiple biopsies

Outcome measures

Outcome data not reported

Adverse Events

For Cause

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Surveillance

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	For Cause n=20 participants at risk For cause biopsy to evaluate a recent rise in serum creatinine. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.	Surveillance n=20 participants at risk Surveillance biopsy done after transplant mostly looking for subclinical rejection. Optison Ultrasound (US): A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow. Contrast-enhanced ultrasound (CEUS): Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.
Blood and lymphatic system disorders Major Bleeding Complications	10.0% 2/20 • Number of events 2 • Adverse events were collected from time of biopsy to 1 week post biopsy.	5.0% 1/20 • Number of events 1 • Adverse events were collected from time of biopsy to 1 week post biopsy.

Other adverse events

Adverse event data not reported

Additional Information

J. Scott Kriegshauser

Mayo Clinic

Phone: 480-342-5664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place