Clinical trial NCT01141816: Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Kidney Lesions
Official title: Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Renal Lesions: a Prospective, Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Renal Cell
Keywords: renal cell carcinoma
radiofrequency ablation
contrast enhanced ultrasound
monitoring
follow up
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2010-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility 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)

Primary outcomes:
measure: Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
timeFrame: 3 months post radiofrequency ablation procedure.
measure: Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
timeFrame: 6 months post radiofrequency ablation procedure.
measure: Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
timeFrame: 12 months post radiofrequency ablation procedure.
measure: Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
timeFrame: 18 months post radiofrequency ablation procedure.
measure: Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
timeFrame: 24 months post radiofrequency ablation procedure.
Secondary outcomes:
measure: Quality of life data
timeFrame: 3 months post radiofrequency ablation
measure: Quality of life data
timeFrame: 6 months post radiofrequency ablation
measure: Quality of life data
timeFrame: 12 months post radiofrequency ablation
measure: Quality of life data
timeFrame: 18 months post radiofrequency ablation
measure: Quality of life data
timeFrame: 24 months post radiofrequency ablation
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Anil Kapoor, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: