Contrast-Enhanced Ultrasound for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: john eisenbrey

Disqualifiers: Medically unstable, Terminally ill, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

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.

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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.

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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.

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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.

I am 18 years old or older.

Be medically stable

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.

Trial 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

Participant Groups

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.

Group I: Diagnostic (CEUS with MRI/CT) Experimental Treatment 5 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

Research Locations Nearby Select from list below to view details:

Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia, PA

Who Is Running the Clinical Trial?

john eisenbrey Lead Sponsor

Thomas Jefferson University Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Ultrasound (CEUS) in the Evaluation of Renal Masses with Histopathological Validation-Results from a Prospective Single-Center Study. [2022] To evaluate the diagnostic accuracy of contrast-enhanced ultrasound (CEUS) in characterizing between malignant and benign renal lesions confirmed by histological examination.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Contrast-Enhanced Ultrasound in Renal Cancer: A Meta-Analysis. [2022] Contrast-enhanced ultrasound (CEUS) is an examination mode for detecting blood vessels in tissues, and it has been gradually used in the diagnosis of kidney cancer in recent years. This study explores the value of contrast-enhanced ultrasound in the clinical diagnosis of renal cancer, and provides an accurate and effective method for clinical diagnosis of renal cancer.

3. England pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Contrast-Enhanced Ultrasound Features for WHO/ISUP Grading in Renal Cell Carcinoma. [2023] By analyzing the differences of contrast-enhanced ultrasound (CEUS) features between low- and high-grade of WHO/ISUP grading, to explore the diagnostic value of CEUS in evaluating the prognosis of renal cell carcinoma (RCC).

4. England pubmed.ncbi.nlm.nih.gov

Effects of Contrast-Enhanced Ultrasound of Indeterminate Renal Masses on Patient Clinical Management: Retrospective Analysis From 2 Institutions. [2021] To investigate the long-term impact of contrast-enhanced ultrasound (CEUS) on the treatment of patients with indeterminate renal masses.

5. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasound (CEUS) of benign and malignant renal tumors: Distinguishing CEUS features differ with tumor size. [2023] Contrast-enhanced ultrasound (CEUS) is now a guideline-recommended strategy for diagnosing renal lesions. Tumor size is related to the risk of the treatment and prognosis in renal tumors. Thus, we aim to analyze the CEUS features of solid renal tumors in relation to tumor size.

6. Netherlands pubmed.ncbi.nlm.nih.gov

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 (CEUS) has the potential to be a valuable alternative to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMR), the current gold standards in characterisation of renal masses.

7. United States pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound of the kidneys: what is it capable of? [2022] One of the many imaging uses of contrast enhanced ultrasound (CEUS) is studying a wide variety of kidney pathology, due to its ability to detect microvascular blood flow in real time without affecting renal function. CEUS enables dynamic assessment and quantification of microvascularisation up to capillary perfusion. The objective of this paper is to briefly refresh basic knowledge of ultrasound (US) contrast agents' physical properties, to study technical details of CEUS scanning in the kidneys, and to review the commonest renal indications for CEUS, with imaging examples in comparison to baseline unenhanced US and computed tomography when performed. Safety matters and limitations of CEUS of the kidneys are also discussed.

8. United States pubmed.ncbi.nlm.nih.gov

Safety of contrast-enhanced ultrasonography in dogs and cats: 488 cases (2002-2011). [2013] To determine the incidence of adverse events within 24 hours after contrast-enhanced ultrasonography (CEUS) in dogs and cats and compare the risk of death within 24 hours after imaging for animals that underwent ultrasonography with and without injection of a contrast agent.

9. Italy pubmed.ncbi.nlm.nih.gov

[Contrast enhanced ultrasound in renal diseases]. [2016] Contrast-enhanced ultrasound (CEUS) is one of the most interesting and promising clinical applications of imaging and ultrasound. Thanks to the absence of ionizing radiation, the lack of nephrotoxicity and low cost it has the potential to become a reference in imaging of the kidney. This review, besides providing a brief description of the proper methodology, presents possible applications of CEUS in nephrology and urology, including renal ischemia, the differential diagnosis of cystic and solid lesions, follow-up of ablative therapies, kidney trauma, kidney transplant, inflammatory diseases, ischemic nephropathy and vesicoureteral reflux.

10. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of renal lesions using contrast-enhanced ultrasound (CEUS); a 10-year retrospective European single-centre analysis. [2022] To investigate the usefulness of contrast-enhanced ultrasound (CEUS) in the evaluation of renal masses.