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Contrast-Enhanced Ultrasound for Kidney Cancer

Q: Is the Diagnostic (CEUS with MRI/CT) technology approved by the FDA?

<p>Based on the available data, Diagnostic (CEUS with <a href="https://www.withpower.com/clinical-trials/mri">MRI</a>/CT)'s safety was rated 2. This is because Phase 2 trials have demonstrated some level of security but not enough to confirm efficacy.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Renal cell carcinoma recurrence

Secondary outcome measures

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

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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Sulfur Hexafluoride Lipid Microspheres

2018

Completed Early Phase 1

~10

Contrast-Enhanced Ultrasound

2018

Completed Early Phase 1

~50

Computed Tomography

2017

Completed Phase 2

~2720

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

john eisenbreyLead Sponsor

1 Previous Clinical Trials

266 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,062 Total Patients Enrolled

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,504 Total Patients Enrolled

Media Library

Renal Cell Carcinoma Research Study Groups: Diagnostic (CEUS with MRI/CT)

Renal Cell Carcinoma Clinical Trial 2023: Contrast-Enhanced Ultrasound Highlights & Side Effects. Trial Name: NCT05641935 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for those wanting to participate in this experiment?

"Yes, the clinicaltrials.gov portal attests to this medical study's active recruitment status. It was first announced on November 3rd 2022 and then altered on November 29th of that same year; 210 patients need to be enrolled from 1 research site."

Answered by AI

Is the Diagnostic (CEUS with MRI/CT) technology approved by the FDA?

"Based on the available data, Diagnostic (CEUS with MRI/CT)'s safety was rated 2. This is because Phase 2 trials have demonstrated some level of security but not enough to confirm efficacy."

Answered by AI

What is the total number of participants in this research study?

"Affirmative. Clinicaltrials.gov affirms that this clinical experiment, which was introduced on November 3rd 2022, is currently recruiting participants. The research requires 210 individuals to be enlisted from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation

john eisenbrey 2022. "Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05641935.

All > Renal Cell Carcinoma