LCCC 1219: A Prospective Pilot Study Evaluating Renal Lesions Through Contrast-enhanced US in Patients With Renal Cancer and in Those With a Risk Factor for Renal Malignancy
Overview
- Phase
- Early Phase 1
- Intervention
- Contrast-enhanced Ultrasound
- Conditions
- Kidney Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide written informed consent
- •Willing to comply with protocol requirements
- •At least 18 years of age
- •Be eligible for radical or partial nephrectomy or ablative therapy based upon at least one renal lesion identified during previous contrast enhanced CT or MR.
- •High risk group (patient recommended for routine surveillance screening for renal malignancy)
- •Have at least one kidney lesion identified but incompletely characterized on a screening US, CT, or MR exam
Exclusion Criteria
- •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 (Blood pressure: systolic blood pressure (BP) \>150 mm Hg and/or diastolic BP \>90 mm Hg despite optimal medical management not controllable by medication to achieve BP \<15/90)
- •Is in an intensive care setting
Arms & Interventions
Contrast-enhanced Ultrasound
Intervention: Contrast-enhanced Ultrasound
Contrast-enhanced Ultrasound
Intervention: Perflutren lipid
Outcomes
Primary Outcomes
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)
Time Frame: 12 months
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.
Secondary Outcomes
- 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(12 months)