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Contrast-Enhanced Ultrasound for Kidney Cancer

Phase 2

Recruiting

Research Sponsored by john eisenbrey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If a female of child-bearing age, must have a negative pregnancy test

Be at least 18 years of age

Must not have

Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well CEUS can diagnose and monitor recurrent RCC after cryo or microwave ablation.

Who is the study for?

This trial is for adults who've had kidney cancer treatment with cryo or microwave ablation and need monitoring for recurrence. They must be medically stable, not pregnant if female of child-bearing age, and have had a contrast-enhanced MRI/CT scan recently.

What is being tested?

The study is testing how good contrast-enhanced ultrasound (CEUS) is at spotting kidney cancer that's come back after ablation. It involves comparing CEUS results with those from standard imaging like MRI/CT scans.

What are the potential side effects?

Potential side effects may include allergic reactions to the ultrasound contrast agent Lumason, which contains sulfur hexafluoride lipid microspheres. Patients with severe lung conditions are excluded due to higher risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am of child-bearing age and my pregnancy test is negative.

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I am 18 years old or older.

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I have had a contrast-enhanced MRI or CT scan before my targeted therapy.

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I have had cryotherapy or microwave therapy for kidney cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe emphysema, pulmonary vasculitis, or a history of blood clots in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Renal cell carcinoma recurrence

Secondary study objectives

Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion

Measurement with multimodality 3D CEUS to improve detection of recurrence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CEUS with MRI/CT)Experimental Treatment5 Interventions

Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulfur Hexafluoride Lipid Microspheres

2018

Completed Early Phase 1

~10

Computed Tomography

2017

Completed Phase 2

~2740