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

Sponsor

St. Joseph's Healthcare Hamilton (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01141816

Collaborator

McMaster University (Other)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Other: Contrast-Enhanced Ultrasound	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

The radiologist is blinded to either CEUS or CT/MRI.

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life data [3 months post radiofrequency ablation]
Quality of life data [6 months post radiofrequency ablation]
Quality of life data [12 months post radiofrequency ablation]
Quality of life data [18 months post radiofrequency ablation]
Quality of life data [24 months post radiofrequency ablation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)