Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer

March 15, 2017 updated by: UNC Lineberger Comprehensive Cancer Center

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 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

    OR

  5. Cohort 2:

    • 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:

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

  9. 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
  10. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contrast-enhanced Ultrasound
Procedure: Contrast-enhanced Ultrasound
All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
Other Names:
  • Contrast-enhanced US
Drug: Perflutren lipid
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.
Other Names:
  • Definity®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Kimryn Rathmell, MD, University of North Carolina
  • Principal Investigator: Wui Chong, MBBS, FRCR, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 18, 2012

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 1219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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