Contrast-enhanced Ultrasound of the Kidney

NCT ID: NCT02684435

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-07-09

Brief Summary

The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies

Detailed Description

This is an investigator-initiated, prospective study designed to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) with microbubble contrast agent (perflutren lipid; Definity®) to identify malignancy in patients with kidney disease, a known risk factor for kidney malignancy, in whom a conventional ultrasound (US) shows an indeterminate cystic kidney lesion.

The primary objective of the study is to estimate the sensitivity of CEUS in diagnosing kidney malignancy in patients with a risk factor for kidney malignancy and compare it to the current gold standard test in this patient population. Secondary analysis will include more optimal contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in a subset of patients who can receive these studies. The study outcome will lead to immediate clinical application in patients with chronic kidney disease. Given the cost-effectiveness and adverse event profile, it has excellent potential to become established as first line diagnostics in the general patient population as well.

Conditions

Chronic Kidney Disease; Cystic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Perflutren lipid microsphere

Intervention Type: DRUG

Dosing per approved package label

Interventions

Perflutren lipid microsphere

Dosing per approved package label

Intervention Type: DRUG

Other Intervention Names

Definity®; Microbubble contrast agent

Eligibility Criteria

Inclusion Criteria

To be eligible for the present study, patients must meet the following criteria:

1. Able to provide written informed consent

2. Willing to comply with protocol requirements

3. At least 18 years of age

4. Have kidney disease, defined as either CKD II-VI, determined by estimated glomerular filtration rate (GFR) of <90 and derived from serum creatinine measurements, or albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to creatinine ratio of >30mg/gm, or having received a kidney transplant

5. Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with an additional imaging tests.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded for enrollment:

1. Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)

2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)

3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome

4. Active cardiac disease including any of the following:

• Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
• Unstable angina.
• Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T- wave, multifocal complexes).
• Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
• Uncontrolled systemic hypertension (systolic blood pressure (BP) >180 mm Hg and/or diastolic BP >100 mm Hg despite optimal medical management

5. Is in an intensive care setting

6. Has an unstable neurological disease (e.g cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent

7. Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast

8. Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:

• Mental illness
• Drug abuse

9. Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative serum or urine beta human chorionic gonadotropin results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)

10. Obesity that limits obtainment of acceptable images

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Chang, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina Kidney Center 7024 Burnett Womack CB #7155 Chapel Hill, NC 27599-7155

Locations

University of North Carolina of Chapel hill

Chapel Hill, North Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

References

Maisonneuve P, Agodoa L, Gellert R, Stewart JH, Buccianti G, Lowenfels AB, Wolfe RA, Jones E, Disney AP, Briggs D, McCredie M, Boyle P. Cancer in patients on dialysis for end-stage renal disease: an international collaborative study. Lancet. 1999 Jul 10;354(9173):93-9. doi: 10.1016/s0140-6736(99)06154-1.

Reference Type: BACKGROUND

PMID: 10408483 (View on PubMed)

Lindner JR. Microbubbles in medical imaging: current applications and future directions. Nat Rev Drug Discov. 2004 Jun;3(6):527-32. doi: 10.1038/nrd1417. No abstract available.

Reference Type: BACKGROUND

PMID: 15173842 (View on PubMed)

Lind Ramskov K, Thomsen HS. Nephrogenic systemic fibrosis and contrast medium-induced nephropathy: a choice between the devil and the deep blue sea for patients with reduced renal function? Acta Radiol. 2009 Nov;50(9):965-7. doi: 10.3109/02841850903209218. No abstract available.

Reference Type: BACKGROUND

PMID: 19863403 (View on PubMed)

Nicolau C, Bunesch L, Pano B, Salvador R, Ribal MJ, Mallofre C, Sebastia C. Prospective evaluation of CT indeterminate renal masses using US and contrast-enhanced ultrasound. Abdom Imaging. 2015 Mar;40(3):542-51. doi: 10.1007/s00261-014-0237-3.

Reference Type: BACKGROUND

PMID: 25209216 (View on PubMed)

Ascenti G, Mazziotti S, Zimbaro G, Settineri N, Magno C, Melloni D, Caruso R, Scribano E. Complex cystic renal masses: characterization with contrast-enhanced US. Radiology. 2007 Apr;243(1):158-65. doi: 10.1148/radiol.2431051924.

Reference Type: BACKGROUND

PMID: 17392251 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

15-1866

Identifier Type: -

Identifier Source: org_study_id