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

NCT ID: NCT01141816

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Keywords

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renal cell carcinoma radiofrequency ablation contrast enhanced ultrasound monitoring follow up

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

The radiologist is blinded to either CEUS or CT/MRI.

Study Groups

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Contrast-Enhanced Ultrasound

Group Type EXPERIMENTAL

Contrast-Enhanced Ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Anil Kapoor

MD, FRCSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anil Kapoor, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MIURCCCEUS

Identifier Type: -

Identifier Source: org_study_id