Contrast-enhanced Ultrasound of the Kidney

NCT02684435 | Completed Phase 2 Results

• 1 other identifier: 15-1866
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Kidney Disease; Cystic Kidney Disease

Outcome Measures

Primary Outcomes (3)

• Number of Lesions With a Change in Radiologist's Evaluation

  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.

  Baseline, 1 year

• Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy

  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

  Baseline, 1 year

• Specificity of Qualitative Interpretations of CEUS

  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

  Baseline, 1 year

Secondary Outcomes (2)

• 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

  Baseline, 1 Year

• 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

  Baseline, 1 Year

Study Arms (1)

Perflutren lipid microsphere

EXPERIMENTAL

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

Drug: Perflutren lipid microsphere

Interventions

Perflutren lipid microsphere DRUG

Dosing per approved package label

Also known as: Definity®, Microbubble contrast agent

Perflutren lipid microsphere

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the present study, patients must meet the following criteria:
• Able to provide written informed consent
• Willing to comply with protocol requirements
• At least 18 years of age
• 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
• 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.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded for enrollment:
• 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)
• Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
• 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
• Is in an intensive care setting
• Has an unstable neurological disease (e.g cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
• Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Vanderbilt University: collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (2)

University of North Carolina of Chapel hill

Chapel Hill, North Carolina, 27599-7510, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

• 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.

  PMID: 10408483 BACKGROUND

• 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.

  PMID: 15173842 BACKGROUND

• 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.

  PMID: 19863403 BACKGROUND

• 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.

  PMID: 25209216 BACKGROUND

• 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.

  PMID: 17392251 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases, Cystic

Interventions

perflutren

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Director of Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Emily Chang, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 18, 2016
• Study Start: February 1, 2016
• Primary Completion: July 9, 2018
• Study Completion: July 9, 2018
• Last Updated: September 26, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)