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

This study is not yet open for participant recruitment.
Verified December 2013 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01141816
First received: June 9, 2010
Last updated: December 2, 2013
Last verified: December 2013

June 9, 2010
December 2, 2013
February 2014
October 2014   (final data collection date for primary outcome measure)
  • Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI. [ Time Frame: 3 months post radiofrequency ablation procedure. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months post radiofrequency ablation procedure. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 months post radiofrequency ablation procedure. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 18 months post radiofrequency ablation procedure. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24 months post radiofrequency ablation procedure. ] [ Designated as safety issue: No ]
    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.
  • 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 after radiofrequency ablation procedure ] [ Designated as safety issue: No ]
  • 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 after radiofrequency ablation procedure ] [ Designated as safety issue: No ]
  • 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 after radiofrequency ablation procedure ] [ Designated as safety issue: No ]
  • 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 after radiofrequency ablation procedure ] [ Designated as safety issue: No ]
  • 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 after radiofrequency ablation procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01141816 on ClinicalTrials.gov Archive Site
  • Quality of life data [ Time Frame: 3 months post radiofrequency ablation ] [ Designated as safety issue: No ]
  • Quality of life data [ Time Frame: 6 months post radiofrequency ablation ] [ Designated as safety issue: No ]
  • Quality of life data [ Time Frame: 12 months post radiofrequency ablation ] [ Designated as safety issue: No ]
  • Quality of life data [ Time Frame: 18 months post radiofrequency ablation ] [ Designated as safety issue: No ]
  • Quality of life data [ Time Frame: 24 months post radiofrequency ablation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Kidney Lesions
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Carcinoma, Renal Cell
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.
Experimental: Contrast-Enhanced Ultrasound
Intervention: Other: Contrast-Enhanced Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
June 2015
October 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Anil Kapoor, MD, FRCSC (905) 522-6536 akapoor@mcmaster.ca
Contact: Camilla Tajzler, BA (905) 522-1155 ext 35876 tajzlec@mcmaster.ca
Canada
 
NCT01141816
MIURCCCEUS
No
Anil Kapoor, St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
McMaster University
Principal Investigator: Anil Kapoor, MD, FRCSC McMaster University
St. Joseph's Healthcare Hamilton
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP