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Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

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ClinicalTrials.gov Identifier: NCT04021238
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with suspected kidney cancer with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: Perflutren lipid microsphere Drug: Sulfur hexafluoride lipid microspheres Phase 4

Detailed Description:

This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Eligible patients will include anyone who has suspected kidney cancer and is scheduled for surgery, up to an anticipated total of 40 participants. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.

Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: Perflutren Lipid Microsphere or Lumason
Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
Drug: Perflutren lipid microsphere
Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
Other Names:
  • Definity
  • Microbubble contrast agent

Drug: Sulfur hexafluoride lipid microspheres
Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
Other Name: Lumason




Primary Outcome Measures :
  1. Predicting kidney mass diagnosis using 3D CEUS generated metrics [ Time Frame: (Baseline) ]
    A 3D volume of regions of interest (ROI) will be calculated using MATLAB. An overall score of each ROI will be derived from multiple parameters from CEUS, B-mode US, and patient factors. A hypothesis test with 95% confidence will be used to test the effects of individual parameters on a fitted logistic regression model to determine the added value of the CEUS measurements.


Secondary Outcome Measures :
  1. Comparing diagnostic accuracy of F-R infusion imaging technique to low MI bolus imaging technique [ Time Frame: (Baseline) ]
    The model-building and evaluation strategy used for the primary objective will be used for bolus and infusion imaging modalities separately as well as in a combined multiparametric score. Standard errors will be obtained by bootstrapping correcting for the fact that both are derived from the same data and thus correlated.

  2. Predicting kidney mass stage using 3D CEUS-generated metrics [ Time Frame: (Baseline) ]
    The continuous variables WI and WO will be used to predict the binary measure of stage T3 or greater disease. We will calculate means (standard deviations) and 95% confidence intervals for WI and WO for those ≥ stage T3 vs. < stage T3, and compare via t-tests at alpha=.05. Logistic regression will be used to assess the abilities of WI and WO to predict stage T3 disease or greater, both separately and combined.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
  • Able to provide informed consent
  • Willing to comply with protocol requirements
  • At least 18 years of age

Exclusion Criteria:

  • Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable
  • Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
  • Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
  • Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives
  • Unstable cardiopulmonary 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
    • Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
    • Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
  • Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021238


Contacts
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Contact: Shanah Kirk 919-966-6957 shanah_kirk@med.unc.edu
Contact: Hannah Mignosa 984-215-4963 hannah_mignosa@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Shanah Kirk    919-966-6957    shanah_kirk@med.unc.edu   
Contact: Hannah Mignosa    984-215-4963    hannah_mignosa@med.unc.edu   
Principal Investigator: Emily Chang, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Emily Chang, MD University of North Carolina, Chapel Hill

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04021238     History of Changes
Other Study ID Numbers: LCCC1922
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type