An Early Phase 1 interventional study of Contrast-enhanced Ultrasound and Perflutren lipid in Kidney Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-17.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Early Phase 1, Interventional, and Diagnostic
This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).
This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 48 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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Cohort 1:
OR
Cohort 2:
Exclusion Criteria:
Active cardiac disease including any of the following:
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:
Procedure: Contrast-enhanced Ultrasound · Drug: Perflutren lipid
All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
Also known as: Contrast-enhanced US
All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
Also known as: Definity®
Feasibility of using contrast-enhanced ultrasound in diagnosing renal malignancy in patients with known renal disease (Cohort 1) and in patients with a risk factor for renal malignancy diagnosed with suspicious or indeterminate lesions (Cohort 2)
Primary analyses will include 1) estimating the sensitivity of contrast enhanced ultrasound in Cohort 1 using the pathological outcome or biopsy result from ablative therapy as gold standard and 2) estimating sensitivity in Cohort 2 using pathology and follow-up results as gold standard (when tissue biopsy is not indicated nor surgery planned the truth standard diagnosis will be based on 12 month follow-up data of disease status). Exact 95% confidence intervals for sensitivity estimate will be reported.
Time frame: 12 months
Feasibility of comparing the sensitivity and specificity of contrast enhanced ultrasound to traditional imaging techniques (CT and MRI) in detecting renal lesions in patients already diagnosed with a renal malignancy
The estimates obtained in Cohort 1 will be compared to the published figures of the conventional CT and MRI method. For Cohort 2 patients who undergo surgery, the percentage of subjects who are correctly diagnosed (benign and malignancy) will be reported along with exact 95% CI. Frequency tables will be used to describe associations. Appropriate descriptive summary statistics such as mean, median and standard deviation of tumor measurement will be provided to quantify and characterize renal masses.
Time frame: 12 months
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center