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

NCT01141816 | Unknown

• 1 other identifier: MIURCCCEUS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Keywords

renal cell carcinoma; radiofrequency ablation; contrast enhanced ultrasound; monitoring; follow up

Outcome Measures

Primary Outcomes (5)

• 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.

  24 months post radiofrequency ablation procedure.

Secondary Outcomes (5)

• 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

Study Arms (1)

Contrast-Enhanced Ultrasound

EXPERIMENTAL

Other: Contrast-Enhanced Ultrasound

Interventions

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.

Contrast-Enhanced Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Anil Kapoor, MD, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiologist is blinded to either CEUS or CT/MRI.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: January 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

CA (1)