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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 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: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention
Carcinoma, Renal Cell
Other: Contrast-Enhanced Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Renal Lesions: a Prospective, Blinded Study

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141816

Contacts
Contact: Anil Kapoor, MD, FRCSC (905) 522-6536 akapoor@mcmaster.ca
Contact: Camilla Tajzler, BA (905) 522-1155 ext 35876 tajzlec@mcmaster.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Anil Kapoor, MD, FRCSC         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
Principal Investigator: Anil Kapoor, MD, FRCSC McMaster University
  More Information

No publications provided

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01141816     History of Changes
Other Study ID Numbers: MIURCCCEUS
Study First Received: June 9, 2010
Last Updated: July 14, 2014
Health Authority: Canada: St. Joseph's Healthcare Hamilton Research Ethics Board

Keywords provided by St. Joseph's Healthcare Hamilton:
renal cell carcinoma
radiofrequency ablation
contrast enhanced ultrasound
monitoring
follow up

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014