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

Primary Purpose

Carcinoma, Renal Cell

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Contrast-Enhanced Ultrasound
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Carcinoma, Renal Cell focused on measuring renal cell carcinoma, radiofrequency ablation, contrast enhanced ultrasound, monitoring, follow up

Eligibility Criteria

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

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)

Sites / Locations

  • St. Joseph's Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast-Enhanced Ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
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.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
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.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
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.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
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.
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
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.

Secondary Outcome Measures

Quality of life data
Quality of life data
Quality of life data
Quality of life data
Quality of life data

Full Information

First Posted
June 9, 2010
Last Updated
December 14, 2021
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01141816
Brief Title
Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Kidney Lesions
Official Title
Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Renal Lesions: a Prospective, Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
renal cell carcinoma, radiofrequency ablation, contrast enhanced ultrasound, monitoring, follow up

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The radiologist is blinded to either CEUS or CT/MRI.
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contrast-Enhanced Ultrasound
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Contrast-Enhanced Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Description
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.
Time Frame
3 months post radiofrequency ablation procedure.
Title
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Description
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.
Time Frame
6 months post radiofrequency ablation procedure.
Title
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Description
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.
Time Frame
12 months post radiofrequency ablation procedure.
Title
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Description
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.
Time Frame
18 months post radiofrequency ablation procedure.
Title
Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Description
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.
Time Frame
24 months post radiofrequency ablation procedure.
Secondary Outcome Measure Information:
Title
Quality of life data
Time Frame
3 months post radiofrequency ablation
Title
Quality of life data
Time Frame
6 months post radiofrequency ablation
Title
Quality of life data
Time Frame
12 months post radiofrequency ablation
Title
Quality of life data
Time Frame
18 months post radiofrequency ablation
Title
Quality of life data
Time Frame
24 months post radiofrequency ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Kapoor, MD, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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

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