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Phase 2 N=63 Diagnostic

Contrast-enhanced Ultrasound of the Kidney

Chronic Kidney Disease · Cystic Kidney Disease

Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Lesions With a Change in Radiologist's Evaluation — 24 lesions

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Perflutren lipid microsphere (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Lesions With a Change in Radiologist's Evaluation
24
PRIMARY
Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy
75
PRIMARY
Specificity of Qualitative Interpretations of CEUS
71
SECONDARY
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
SECONDARY
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

Summary

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

Eligibility Criteria

Inclusion Criteria

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 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.

Exclusion Criteria

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
  • Drug abuse
  • 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)
  • Obesity that limits obtainment of acceptable images

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View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02684435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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