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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

18 Years
Not Enrolling
Kidney Cancer

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Trial Information

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

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).

Inclusion Criteria:

1. Able to provide written informed consent

2. Willing to comply with protocol requirements

3. At least 18 years of age

4. Cohort 1:

- Be scheduled for radical or partial nephrectomy or ablative therapy based upon
at least one renal lesion identified during previous contrast enhanced CT or MR.


5. Cohort 2:

- High risk group (patient undergoing routine surveillance screening for renal

- Have at least one kidney lesion identified but incompletely characterized on a
screening US, CT, or MR exam

Exclusion Criteria:

1. 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)

2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid

3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure
>90mmHg), or adult respiratory distress syndrome

4. 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®

- 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)

5. Is in an intensive care setting

6. Has an unstable neurological disease (e.g recent stroke or TIA symptoms (<3 months))
cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3
months before signing of informed consent

7. Undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery,
nonsurgical cytoreductive procedure) in-between identification of lesion via US
without contrast and perflutren lipid administration

8. Receiving any other contrast medium, within the 48 hours before and up to 24 hours
following the administration of perflutren

9. Has previously been entered into this study or has received an investigational drug
within the 30 days prior to admission into this study

10. 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

11. Female patient who is pregnant or lactating (the possibility of pregnancy has to be
excluded by negative serum or urine B-HCG 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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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)

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Kimryn Rathmell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina


United States: Food and Drug Administration

Study ID:

LCCC 1219



Start Date:

May 2013

Completion Date:

February 2020

Related Keywords:

  • Kidney Cancer
  • renal malignancy
  • Pilot Study
  • LCCC 1219
  • UNC Lineberger
  • kidney cancer
  • contrast-enhanced ultrasound
  • ultrasound
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599-7305