210 Participants Needed

Contrast-Enhanced Ultrasound for Kidney Cancer

JE
Overseen ByJohn Eisenbrey, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: john eisenbrey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Contrast-Enhanced Ultrasound for Kidney Cancer?

Research shows that contrast-enhanced ultrasound (CEUS) is effective in diagnosing kidney cancer by accurately distinguishing between cancerous and non-cancerous kidney masses, which helps in better clinical management and treatment planning.12345

Is contrast-enhanced ultrasound (CEUS) safe for humans?

Contrast-enhanced ultrasound (CEUS) is generally considered safe for humans, as it allows for real-time imaging without affecting kidney function. While specific safety data for humans is not detailed in the provided research, CEUS is a guideline-recommended strategy for diagnosing kidney issues, suggesting its safety is well-regarded in medical practice.25678

How is the treatment Contrast-Enhanced Ultrasound (CEUS) different from other treatments for kidney cancer?

Contrast-Enhanced Ultrasound (CEUS) is unique because it uses sound waves and a special contrast agent to create detailed images of blood flow in kidney tissues, helping to diagnose kidney cancer without the use of ionizing radiation or nephrotoxic agents, making it safer and potentially more cost-effective than traditional imaging methods like CT or MRI.256910

What is the purpose of this trial?

This phase II trial studies how well contrast-enhanced ultrasound (CEUS) works for diagnosing patients with renal cell cancer (RCC) that has come back (recurrent) after an ablation. Diagnostic imaging, such as CEUS, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.

Eligibility Criteria

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.

Inclusion Criteria

I am of child-bearing age and my pregnancy test is negative.
Be medically stable
I've had or will have an MRI/CT with contrast for RCC monitoring within 4 weeks.
See 3 more

Exclusion Criteria

Patients who are medically unstable, seriously or terminally ill, or whose clinical course is unpredictable
You are allergic to any of the ingredients in Lumason.
I have severe emphysema, pulmonary vasculitis, or a history of blood clots in my lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study

Up to 2 years
Every 6 months

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

Up to 2 years
Every 6 months

Treatment Details

Interventions

  • Contrast-Enhanced Ultrasound
  • Sulfur Hexafluoride Lipid Microspheres
Trial Overview 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.
Participant Groups
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.

Contrast-Enhanced Ultrasound is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as CEUS for:
  • Diagnosis of renal cell carcinoma
  • Monitoring of recurrent renal cell carcinoma
🇺🇸
Approved in United States as CEUS for:
  • Diagnosis of renal cell carcinoma
  • Monitoring of recurrent renal cell carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

john eisenbrey

Lead Sponsor

Trials
2
Recruited
480+

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Contrast-enhanced ultrasound (CEUS) was evaluated in 110 patients with 118 renal masses, showing a high diagnostic accuracy for distinguishing between malignant (75%) and benign (25%) lesions confirmed by histology.
The combination of peak intensity and area under the curve from CEUS provided the best results, achieving a sensitivity of 93% and a specificity of 100%, significantly improving the ability to accurately classify renal lesions.
Contrast-Enhanced Ultrasound (CEUS) in the Evaluation of Renal Masses with Histopathological Validation-Results from a Prospective Single-Center Study.Tufano, A., Drudi, FM., Angelini, F., et al.[2022]
Contrast-enhanced ultrasound (CEUS) has demonstrated high diagnostic value for renal cell carcinoma (RCC), with a sensitivity of 97% and specificity of 86% based on a meta-analysis of 20 studies.
The area under the curve (AUC) for CEUS in diagnosing RCC was 0.97, indicating excellent overall diagnostic performance, although the studies showed high heterogeneity.
Diagnostic Performance of Contrast-Enhanced Ultrasound in Renal Cancer: A Meta-Analysis.Pan, KH., Jian, L., Chen, WJ., et al.[2022]
A study of 69 patients with renal cell carcinoma (RCC) found that contrast-enhanced ultrasound (CEUS) can effectively differentiate between low-grade and high-grade tumors based on specific features, such as peak intensity (∆PI).
CEUS demonstrated a sensitivity of 70.2% and specificity of 71.4% for distinguishing between low-grade and high-grade RCC, indicating its potential as a valuable tool for preoperative prognosis evaluation.
Diagnostic Value of Contrast-Enhanced Ultrasound Features for WHO/ISUP Grading in Renal Cell Carcinoma.Huang, X., Nie, F., Zhu, J., et al.[2023]

References

Contrast-Enhanced Ultrasound (CEUS) in the Evaluation of Renal Masses with Histopathological Validation-Results from a Prospective Single-Center Study. [2022]
Diagnostic Performance of Contrast-Enhanced Ultrasound in Renal Cancer: A Meta-Analysis. [2022]
Diagnostic Value of Contrast-Enhanced Ultrasound Features for WHO/ISUP Grading in Renal Cell Carcinoma. [2023]
Effects of Contrast-Enhanced Ultrasound of Indeterminate Renal Masses on Patient Clinical Management: Retrospective Analysis From 2 Institutions. [2021]
Contrast-enhanced ultrasound (CEUS) of benign and malignant renal tumors: Distinguishing CEUS features differ with tumor size. [2023]
Comparison of the Diagnostic Performance of Contrast-enhanced Ultrasound with That of Contrast-enhanced Computed Tomography and Contrast-enhanced Magnetic Resonance Imaging in the Evaluation of Renal Masses: A Systematic Review and Meta-analysis. [2021]
Contrast enhanced ultrasound of the kidneys: what is it capable of? [2022]
Safety of contrast-enhanced ultrasonography in dogs and cats: 488 cases (2002-2011). [2013]
[Contrast enhanced ultrasound in renal diseases]. [2016]
Evaluation of renal lesions using contrast-enhanced ultrasound (CEUS); a 10-year retrospective European single-centre analysis. [2022]
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