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