Contrast-Enhanced Ultrasound for Kidney Cancer

Overseen By John Eisenbrey, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: john eisenbrey

Disqualifiers: Medically unstable, Terminally ill, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of contrast-enhanced ultrasound (CEUS) in diagnosing kidney cancer that has returned after treatments like cryo or microwave ablation. CEUS, a type of imaging, may help doctors see and monitor kidney cancer. The trial aims to determine if CEUS can match the effectiveness of other imaging methods like MRI or CT scans. Individuals who have undergone cryotherapy or microwave therapy for kidney cancer and have had or will have MRI/CT imaging might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in kidney cancer diagnosis.

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 prior data suggests that contrast-enhanced ultrasound is safe for diagnosing kidney cancer recurrence?

Research has shown that contrast-enhanced ultrasound (CEUS) provides a safe and accurate method for monitoring kidney cancer. One study found CEUS to be cost-effective and highly effective at detecting cancerous growths, reliably identifying cancer cells. Another study determined that CEUS is safer for patients with kidney failure compared to other imaging methods.

The specific contrast agent used in CEUS, Lumason, has undergone safety testing. Animal studies revealed no harmful effects. In humans, the death rate for patients who received Lumason was very low, at only 0.03%.

Overall, CEUS and Lumason have demonstrated safety with few side effects, making them a well-tolerated option for those concerned about kidney cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contrast-enhanced ultrasound (CEUS) for kidney cancer because it offers a non-invasive imaging technique that could improve the accuracy of tumor detection and assessment. Unlike traditional imaging methods like CT or MRI, CEUS uses microbubble contrast agents to enhance the ultrasound images, potentially providing clearer and more detailed views of the blood flow in kidney tumors. This could lead to faster, more precise diagnoses without the exposure to radiation or the need for nephrotoxic contrast agents, making it a safer option for patients with kidney issues.

What evidence suggests that contrast-enhanced ultrasound is effective for diagnosing recurrent kidney cancer?

Research has shown that contrast-enhanced ultrasound (CEUS), which participants in this trial will undergo, effectively diagnoses kidney cancer. Studies indicate that CEUS accurately identifies cancerous kidney masses 93% of the time, making it highly reliable. It has a sensitivity of 94%, meaning it correctly detects cancer when present. Additionally, it has a high positive predictive value (PPV) of 95%, indicating that most positive results are true positives. Compared to regular ultrasounds, CEUS provides better images of kidney lesions. This makes it a promising tool for monitoring the return of kidney cancer, aiding doctors in making well-informed decisions with clear images. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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+

Published Research Related to This Trial

Contrast-enhanced ultrasound (CEUS) is a promising imaging technique for kidney evaluation due to its safety profile, as it does not involve ionizing radiation and has low nephrotoxicity.

CEUS can be effectively used in various nephrology and urology applications, including diagnosing renal ischemia, differentiating between cystic and solid lesions, and monitoring kidney transplant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast enhanced ultrasound in renal diseases]. Granata, A., Floccari, F., Logias, F., et al.[2016]

Contrast-enhanced ultrasound (CEUS) shows higher sensitivity in diagnosing renal masses compared to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMR), with sensitivities of 0.96 and 0.98 respectively, indicating it may be a more effective diagnostic tool.

Despite promising results suggesting CEUS could be at least as effective as CECT and CEMR, the current evidence is limited, highlighting the need for more robust studies to confirm these findings.

NCBI (Pubmed)

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. Furrer, MA., Spycher, SCJ., Büttiker, SM., et al.[2021]

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.

NCBI (Pubmed)

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. Tufano, A., Drudi, FM., Angelini, F., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Contrast-Enhanced Ultrasound Features for WHO/ISUP Grading in Renal Cell Carcinoma. Huang, X., Nie, F., Zhu, J., et al.[2023]

In a study of 157 patients with indeterminate renal masses, contrast-enhanced ultrasound (CEUS) provided a definitive treatment recommendation for 71.6% of lesions, significantly aiding in clinical decision-making.

CEUS effectively identified benign lesions, with none of the 118 diagnosed as benign developing renal cell carcinoma later, thus reducing unnecessary follow-ups and the use of nephrotoxic contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Contrast-Enhanced Ultrasound of Indeterminate Renal Masses on Patient Clinical Management: Retrospective Analysis From 2 Institutions. Eisenbrey, JR., Kamaya, A., Gummadi, S., et al.[2021]

Contrast-enhanced ultrasound (CEUS) is a valuable imaging technique for assessing kidney pathology, as it can visualize microvascular blood flow in real time without harming renal function.

CEUS allows for dynamic evaluation of kidney microvascularization and is compared favorably to traditional imaging methods like unenhanced ultrasound and computed tomography, although safety and limitations are also important considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound of the kidneys: what is it capable of? Cokkinos, DD., Antypa, EG., Skilakaki, M., et al.[2022]

In a study of 255 patients, contrast-enhanced ultrasound (CEUS) demonstrated a very high sensitivity of 99.1% and a specificity of 80.5% for distinguishing between malignant and benign renal masses, making it a reliable diagnostic tool.

CEUS not only effectively identified 212 malignant lesions (mostly renal cell carcinomas) but also provided valuable information for appropriate surgical treatment or follow-up, highlighting its importance in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of renal lesions using contrast-enhanced ultrasound (CEUS); a 10-year retrospective European single-centre analysis. Rübenthaler, J., Negrão de Figueiredo, G., Mueller-Peltzer, K., et al.[2022]

In a study involving 750 dogs and cats, contrast-enhanced ultrasonography (CEUS) was found to be safe, with only 3 immediate adverse events and 1 delayed event reported in dogs, and no adverse events in cats.

The risk of death within 24 hours after ultrasonography was similar for animals that underwent CEUS and those that had standard ultrasonography without contrast, indicating that CEUS does not increase mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of contrast-enhanced ultrasonography in dogs and cats: 488 cases (2002-2011). Seiler, GS., Brown, JC., Reetz, JA., et al.[2013]

In a study of 156 solid renal tumors, contrast-enhanced ultrasound (CEUS) effectively detected all lesions and revealed that the characteristics of tumors, such as enhancement degree and presence of a pseudocapsule sign, vary significantly with tumor size.

The analysis showed that the proportion of malignant tumors increased with size, particularly in the 2.1-4 cm range, highlighting the importance of considering tumor size when using CEUS for diagnosing renal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasound (CEUS) of benign and malignant renal tumors: Distinguishing CEUS features differ with tumor size. Zhu, J., Li, N., Zhao, P., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Contrast-Enhanced Ultrasound in Renal Cancer: A Meta-Analysis. Pan, KH., Jian, L., Chen, WJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7703431/

Diagnostic Performance of Contrast-Enhanced Ultrasound ... This study explores the value of contrast-enhanced ultrasound in the clinical diagnosis of renal cancer, and provides an accurate and effective method.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9600471/

Diagnostic Performance of Contrast-Enhanced Ultrasound in ... Diagnostic performance of CEUS showed an accuracy of 0.93 in detecting malignant masses (sensitivity of 0.94, PPV of 0.95, specificity of 0.78, and NPV of 0.73 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0301562925001383

Feasibility of Contrast-Enhanced Ultrasound Fusion With ... Contrast enhanced ultrasound (CEUS) is a cost-effective, safe, and accurate modality for monitoring renal cell carcinoma (RCC) recurrence following ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/38/NCT04021238/Prot_SAP_000.pdf

Contrast-Enhanced Ultrasound for Kidney Cancer ... We propose to investigate an advanced contrast-enhanced ultrasound. (CEUS) technique as a novel imaging tool to address these critical gaps in kidney mass ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12413-4

High-frame-rate contrast-enhanced ultrasound to differentiate ... H-CEUS enhances the sensitivity and specificity of differentiating between CCRCC and AML by improving the temporal resolution, offering a more precise ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5241536/

Impact of contrast-enhanced ultrasound in patients with renal ... Contrast-enhanced ultrasound is a safer imaging tool in patients with RFI, showing 36% detection rate of renal infarction in patients with acute renal failure ...

7. ajronline.org ajronline.org/doi/abs/10.2214/AJR.24.30817

Contrast-Enhanced Ultrasound of the Indeterminate Renal ... CEUS excels in distinguishing solid from cystic renal masses, with higher sensitivity than CT or MRI for detection of enhancement within lesions.