Back to results

Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Perflutren lipid microsphere

Sulfur hexafluoride lipid microspheres

About this trial

This is an interventional diagnostic trial for Kidney Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perflutren Lipid Microsphere or Lumason

Arm Description

Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.

Outcomes

Primary Outcome Measures

Predicting kidney mass diagnosis using 3D CEUS generated metrics

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

Comparing diagnostic accuracy of F-R infusion imaging technique to low MI bolus imaging technique

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.

Predicting kidney mass stage using 3D CEUS-generated metrics

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.

Full Information

NCT ID

NCT04021238

First Posted

July 11, 2019

Last Updated

August 5, 2022

Sponsor

UNC Lineberger Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04021238

Brief Title

Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

Official Title

Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 7, 2020 (Actual)

Primary Completion Date

August 5, 2022 (Actual)

Study Completion Date

August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Perflutren Lipid Microsphere or Lumason

Arm Type

Experimental

Arm Description

Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.

Intervention Type

Drug

Intervention Name(s)

Perflutren lipid microsphere

Other Intervention Name(s)

Definity, Microbubble contrast agent

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sulfur hexafluoride lipid microspheres

Other Intervention Name(s)

Lumason

Intervention Description

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.

Primary Outcome Measure Information:

Title

Predicting kidney mass diagnosis using 3D CEUS generated metrics

Description

Time Frame

(Baseline)

Secondary Outcome Measure Information:

Title

Comparing diagnostic accuracy of F-R infusion imaging technique to low MI bolus imaging technique

Description

Time Frame

(Baseline)

Title

Predicting kidney mass stage using 3D CEUS-generated metrics

Description

Time Frame

(Baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily Chang, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

We'll reach out to this number within 24 hrs