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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-Enhanced Ultrasound | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post radiofrequency ablation procedure. |
| 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. | 6 months post radiofrequency ablation procedure. |
| 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. | 12 months post radiofrequency ablation procedure. |
| 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. | 18 months post radiofrequency ablation procedure. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life data | 3 months post radiofrequency ablation | |
| Quality of life data | 6 months post radiofrequency ablation | |
| Quality of life data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Kapoor, MD, FRCSC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The radiologist is blinded to either CEUS or CT/MRI.
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|
| 24 months post radiofrequency ablation procedure. |
| 12 months post radiofrequency ablation |
| Quality of life data | 18 months post radiofrequency ablation |
| Quality of life data | 24 months post radiofrequency ablation |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |