IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02625428
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus help direct the biopsy to the most abnormal part of the renal cortex. This should maximize detection and increase the odds of demonstrating the true grade/severity of the histopathological abnormality.

Condition or Disease	Intervention/Treatment	Phase
Transplantation, Kidney	Drug: Optison; Diagnostic Test: Ultrasound (US); Diagnostic Test: Contrast-enhanced ultrasound (CEUS)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Does Contrast-Enhanced Ultrasound Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: For Cause For cause biopsies to evaluate a recent rise in serum creatinine.	Drug: Optison; Other Names: ultrasound contrast agent ; Diagnostic Test: 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.; Diagnostic Test: 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.
Experimental: Surveillance Surveillance biopsies done after transplant mostly looking for subclinical rejection.	Drug: Optison; Other Names: ultrasound contrast agent ; Diagnostic Test: 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.; Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

1. Abnormal Biopsy [1 year]

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

Secondary Outcome Measures

1. Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion

• Ability to provide informed consent

• Male and female >18 years

• Patients undergoing renal transplant ultrasound-guided percutaneous biopsy within 24 months post transplant including patients undergoing biopsy to evaluate a recent rise in serum creatinine so called for cause biopsies and patients undergoing routine protocol (surveillance) biopsies without other evident of renal dysfunction

Exclusion:

• Pregnant women or women who are nursing an infant are not able to participate in this study

• Known patent forearm ovale (PFO)

• Significant heart disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: J Kriegshauser, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 26, 2014

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: J. Scott Kriegshauser, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02625428
• Other Study ID Numbers: 14-009240
• First Posted: Dec 9, 2015
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	For Cause	Surveillance
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	For Cause	Surveillance	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.4 (13.4)	50.8 (14.1)	52.6 (13.7)
Sex: Female, Male (Count of Participants)
Female	8 40%	4 20%	12 30%
Male	12 60%	16 80%	28 70%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%
Serum Creatinine (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	3.3 (1.9)	1.5 (0.4)	2.4 (1.6)

Outcome Measures

1. Primary Outcome

Title	Abnormal Biopsy
Description	Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	For Cause	Surveillance
Arm/Group Description	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 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.
Measure Participants	20	20
Count of Participants [Participants]	10 50%	7 35%

2. Secondary Outcome

Title	Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	For Cause	Surveillance
Arm/Group Description	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 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.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were collected from time of biopsy to 1 week post biopsy.
Arm/Group Title	For Cause		Surveillance
Arm/Group Description	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 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.
All Cause Mortality
	For Cause		Surveillance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	For Cause		Surveillance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		1/20 (5%)
Blood and lymphatic system disorders
Major Bleeding Complications	2/20 (10%)	2	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	For Cause		Surveillance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.