Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension

NCT03196076 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-1130
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases; Cystic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Change in Radiologist's Lesion Evaluation

  Lesions will be assessed for change in size, calcification, and septation using Bosniak criteria to determine whether a lesion has progressed, regressed or is stable.

  1 year

Study Arms (3)

Perflutren Lipid Microsphere (Healthy subjects)

EXPERIMENTAL

Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.

Drug: Perflutren Lipid microsphere

Perflutren Lipid Microsphere (patients with kidney lesions)

EXPERIMENTAL

Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.

Drug: Perflutren Lipid microsphere

Controls: No interaction

NO INTERVENTION

Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention.

Interventions

Perflutren Lipid microsphere DRUG

Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.

Also known as: Definity, Microbubble contrast agent

Perflutren Lipid Microsphere (Healthy subjects); Perflutren Lipid Microsphere (patients with kidney lesions)

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 chronic kidney disease (CKD) II-V, 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 within 3 months of recruitment, or on dialysis or having received a kidney transplant or have biopsy proven kidney disease. In these latter cases, blood and urine tests are not necessary.
• 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 additional imaging test(s).

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
• Lantheus Medical Imaging: collaborator

Study Sites (1)

University of North Carolina of Chapel hill

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

Location

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 Burnette 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: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: August 28, 2017
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: July 21, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)