Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Kidney Lesions

December 14, 2021 updated by: Anil Kapoor, St. Joseph's Healthcare Hamilton

Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Renal Lesions: a Prospective, Blinded Study

Radiofrequency ablation (RFA) is an increasingly popular therapy option for treating small kidney cancer, especially for patients who are not ideal candidates for traditional surgery. Currently, follow-up after this procedure involves the patient having several CT scans (or MRI scans in some cases) over time to monitor for possible cancer recurrence. However, there are risks associated with the radiation exposure from CT scans and other risks, such as adverse events from the contrast media used in these scans. This study will therefore investigate whether a different technique, contrast-enhanced ultrasound (CEUS), can be an effective tool for follow-up monitoring of kidney cancer patients who have undergone RFA by comparing the results of their standard follow-up CT scans (or MRIs if applicable) with the results of CEUS. If CEUS is found to be just as effective as CT scans or MRIs in detecting kidney cancer recurrence, this technique could potentially become the new standard of care for follow-up.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare

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:

  • at least 18 years of age and capable of giving informed consent
  • patient undergoing CT of MRI for monitoring of renal lesions after radiofrequency ablation

Exclusion Criteria:

  • pregnant patients
  • patients with allergies to iodinated contrast agents
  • patients with pulmonary hypertension, right-to-left cardiac shunts, or unstable cardiopulmonary disease (these are absolute or relative contraindications to the use of the ultrasound contrast agent, perflutren lipid microsphere)

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: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Contrast-Enhanced Ultrasound
Other: Contrast-Enhanced Ultrasound
Contrast-enhanced ultrasounds of the kidney will be performed within 7 days of routine CTs or MRIs at 3, 6, 12, 18, and 24 months post-radiofrequency ablation, with Perflutren Lipid Microsphere Injectible Suspension ('Definity') as the contrast agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Time Frame: 3 months post radiofrequency ablation procedure.
The accuracy of contrast-enhanced ultrasound in monitoring renal lesions post-radiofrequency ablation will be assessed through sensitivity, specificity, and positive predictive value of CEUS for tumour recurrence and by comparing to the standard CT/ MRI.
3 months post radiofrequency ablation procedure.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Time Frame: 6 months post radiofrequency ablation procedure.
The accuracy of contrast-enhanced ultrasound in monitoring renal lesions post-radiofrequency ablation will be assessed through sensitivity, specificity, and positive predictive value of CEUS for tumour recurrence and by comparing to the standard CT/ MRI.
6 months post radiofrequency ablation procedure.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Time Frame: 12 months post radiofrequency ablation procedure.
The accuracy of contrast-enhanced ultrasound in monitoring renal lesions post-radiofrequency ablation will be assessed through sensitivity, specificity, and positive predictive value of CEUS for tumour recurrence and by comparing to the standard CT/ MRI.
12 months post radiofrequency ablation procedure.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Time Frame: 18 months post radiofrequency ablation procedure.
The accuracy of contrast-enhanced ultrasound in monitoring renal lesions post-radiofrequency ablation will be assessed through sensitivity, specificity, and positive predictive value of CEUS for tumour recurrence and by comparing to the standard CT/ MRI.
18 months post radiofrequency ablation procedure.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Time Frame: 24 months post radiofrequency ablation procedure.
The accuracy of contrast-enhanced ultrasound in monitoring renal lesions post-radiofrequency ablation will be assessed through sensitivity, specificity, and positive predictive value of CEUS for tumour recurrence and by comparing to the standard CT/ MRI.
24 months post radiofrequency ablation procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life data
Time Frame: 3 months post radiofrequency ablation
3 months post radiofrequency ablation
Quality of life data
Time Frame: 6 months post radiofrequency ablation
6 months post radiofrequency ablation
Quality of life data
Time Frame: 12 months post radiofrequency ablation
12 months post radiofrequency ablation
Quality of life data
Time Frame: 18 months post radiofrequency ablation
18 months post radiofrequency ablation
Quality of life data
Time Frame: 24 months post radiofrequency ablation
24 months post radiofrequency ablation

Collaborators and Investigators

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

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

McMaster University

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

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (ESTIMATE)

June 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIURCCCEUS

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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