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The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies
Full 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.
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Inclusion criteria
To be eligible for the present study, patients must meet the following criteria:
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:
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:
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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63 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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