Carcinoma, Renal CellNCT01141816

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

A study testing Contrast-Enhanced Ultrasound in people with Carcinoma, Renal Cell, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Renal Cell
What is being tested?: Contrast-Enhanced Ultrasound
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteCanada
Study dates: Jan 2015to Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Renal Lesions: a Prospective, Blinded Study

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
Being tested: Contrast-Enhanced Ultrasound
Keywords: renal cell carcinoma, radiofrequency ablation, contrast enhanced ultrasound, monitoring, follow up
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contrast-Enhanced UltrasoundOther
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.

Study groups in NCT01141816
Study group	Role	What they receive
Contrast-Enhanced Ultrasound	Experimental	Not described Receives: Other: Contrast-Enhanced Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months post radiofrequency ablation procedure.

Secondary outcomes (5)

Quality of life data
Measured: 3 months post radiofrequency ablation
Quality of life data
Measured: 6 months post radiofrequency ablation
Quality of life data
Measured: 12 months post radiofrequency ablation
Quality of life data
Measured: 18 months post radiofrequency ablation
Quality of life data
Measured: 24 months post radiofrequency ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jan 2022

First posted11 Jun 2010 (estimated)
Study startJan 2015
Primary completionDec 2021 (estimated)
Study completionJan 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01141816
Sponsor's protocol ID: MIURCCCEUS
Status last verified: Dec 2021
First submitted: 9 Jun 2010
Last updated: 16 Dec 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Not yet recruitingPhase 2
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Localized Clear Cell Renal Cell Carcinoma

All Carcinoma, Renal Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Renal Lesions: a Prospective, Blinded Study
ClinicalTrials.gov ID: NCT01141816
Acronym / sponsor ID: MIURCCCEUS
Conditions: Carcinoma, Renal Cell
Keywords: renal cell carcinoma, radiofrequency ablation, contrast enhanced ultrasound, monitoring, follow up
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (actual)
Lead sponsor: St. Joseph's Healthcare HamiltonUniversity, hospital or other
Collaborators: McMaster University
Study start: Jan 2015
Primary completion: Dec 2021 (estimated)
Study completion: Jan 2022 (estimated)
First posted: 11 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Contrast-Enhanced Ultrasound	Experimental	Other: Contrast-Enhanced Ultrasound

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Contrast-Enhanced UltrasoundContrast-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.	Other	Contrast-Enhanced Ultrasound

Primary outcome

Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI.
Time frame: 3 months post radiofrequency ablation procedure.
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.
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.
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.
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.
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.

5 secondary outcomes

Quality of life data
Time frame: 3 months post radiofrequency ablation
Quality of life data
Time frame: 6 months post radiofrequency ablation
Quality of life data
Time frame: 12 months post radiofrequency ablation
Quality of life data
Time frame: 18 months post radiofrequency ablation
Quality of life data
Time frame: 24 months post radiofrequency ablation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.

Related trials for Carcinoma, Renal Cell

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anil Kapoor, MD, FRCSC principal investigator

McMaster University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Contrast-Enhanced Ultrasound in people with Carcinoma, Renal Cell, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity value of CEUS for tumour recurrence and by comparing to the standard CT/MRI. (time frame: 3 months post radiofrequency ablation procedure.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01141816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.