Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Kidney Lesions
This study is not yet open for participant recruitment.
Verified December 2012 by St. Joseph's Healthcare Hamilton
Sponsor:
St. Joseph's Healthcare Hamilton
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 11, 2012
Last verified: December 2012
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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: | May 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (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
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: | December 11, 2012 |
| 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 May 16, 2013