104 Participants Needed

Contrast-Enhanced Ultrasound + Radioembolization for Liver Cancer

JE
Overseen ByJohn Eisenbrey, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Thomas Jefferson University
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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for liver cancer?

Research shows that Yttrium-90 (Y-90) resin microsphere therapy, a part of this treatment, has been effective in treating inoperable liver tumors, including hepatocellular carcinoma (HCC) and liver metastases from other cancers. This therapy delivers targeted radiation to liver tumors while minimizing damage to healthy liver tissue, improving clinical outcomes for selected patients.12345

Is Yttrium-90 radioembolization safe for liver cancer treatment?

Yttrium-90 radioembolization, also known as Selective Internal Radiation Therapy (SIRT), has been used to treat liver tumors by delivering radiation directly to the cancer while minimizing exposure to healthy liver tissue. Studies have shown it to be generally safe for patients with inoperable liver cancer, with careful patient selection and treatment planning being important for minimizing risks.13456

How is the treatment Yttrium-90 Microsphere Radioembolization unique for liver cancer?

Yttrium-90 Microsphere Radioembolization is unique because it delivers high doses of radiation directly to liver tumors through the blood vessels, minimizing exposure to healthy liver tissue. This targeted approach combines radiation therapy with embolization (blocking blood flow to the tumor), making it effective for inoperable liver cancers.13456

What is the purpose of this trial?

This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced ultrasound imaging will "pop" these microbubbles and cause tumors to become more sensitive to radiation therapies.

Research Team

JE

John Eisenbrey, PhD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

This trial is for stable adults with untreated liver cancer (HCC) masses under 6 cm, visible on ultrasound. They must consent to the study and women of childbearing age need a negative pregnancy test before each exam. It's not for critically ill patients, those with high bilirubin levels or heart failure, pregnant/nursing women, or anyone allergic to perflutren.

Inclusion Criteria

Have signed informed consent to participate in the study
I am scheduled for a specific liver cancer treatment for a tumor smaller than 6 cm.
Be medically stable
See 1 more

Exclusion Criteria

I have a known heart shunt.
I have severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism.
I have a history of bleeding disorders.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive perflutren protein-type A microspheres intravenously and undergo contrast-enhanced ultrasound, or undergo standard of care yttrium Y-90 radioembolization

2 weeks
Multiple visits for CEUS at 1-6 hours, 7 days, and 14 days post-radioembolization

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 months
Follow-up visits at 1 month and 3-4 months

Treatment Details

Interventions

  • Dynamic Contrast-Enhanced Ultrasound Imaging
  • Perflutren Protein-Type A Microspheres
  • Yttrium-90 Microsphere Radioembolization
Trial Overview The trial tests if using Perflutren Protein-Type A Microspheres with contrast-enhanced ultrasound can improve the effectiveness of Yttrium-90 radioembolization therapy in treating liver cancer by making tumors more sensitive to radiation.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (perflutren protein-type A microspheres, CEUS)Experimental Treatment3 Interventions
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Group II: Group II (standard of care)Active Control1 Intervention
Patients undergo standard of care yttrium Y-90 radioembolization.

Yttrium-90 Microsphere Radioembolization is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Yttrium-90 Microspheres for:
  • Hepatocellular carcinoma
  • Colorectal cancer liver metastases
🇪🇺
Approved in European Union as Yttrium-90 Microspheres for:
  • Hepatocellular carcinoma
  • Colorectal cancer liver metastases

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials
164
Recruited
10,900+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Selective internal radiotherapy (SIRT) using yttrium-90 microspheres can enhance clinical outcomes for patients with inoperable liver cancer by targeting tumors while protecting healthy tissue.
Effective planning for SIRT is crucial to avoid serious side effects like radiation-induced liver disease, and it is recommended to use multiple planning methods to determine the appropriate microsphere activity for each patient.
Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres.Lau, WY., Kennedy, AS., Kim, YH., et al.[2022]
In a study of 60 patients with liver metastases from colorectal cancer, higher prescribed activity of Yttrium-90 resin microspheres was associated with improved radiographic tumor response at 4-6 months post-treatment, as measured by RECIST criteria.
Overall survival was not significantly linked to the prescribed activity or dose, suggesting that while the treatment may improve tumor response, it does not necessarily extend survival, highlighting the need for better dose calculation models for predicting treatment outcomes.
Correlation of radiation dose and activity with clinical outcomes in metastatic colorectal cancer after selective internal radiation therapy using yttrium-90 resin microspheres.Badiyan, S., Bhooshan, N., Chuong, MD., et al.[2019]
In a study involving 34 patients with unresectable hepatocellular carcinoma (HCC), Yttrium-90 (Y-90) microsphere therapy demonstrated significant efficacy, with 19% achieving complete response and 44% showing partial response after treatment.
The therapy was found to be safe, with no serious side effects reported, and predictors of treatment success included mean tumor dose delivery and the absence of bilobar disease.
Yttrium-90 (Y-90) resin microsphere therapy for patients with unresectable hepatocellular carcinoma. Identification of successful treatment response predictors and patient selection.Arslan, N., Ince, S., Okuyucu, K., et al.[2022]

References

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022]
Correlation of radiation dose and activity with clinical outcomes in metastatic colorectal cancer after selective internal radiation therapy using yttrium-90 resin microspheres. [2019]
Yttrium-90 (Y-90) resin microsphere therapy for patients with unresectable hepatocellular carcinoma. Identification of successful treatment response predictors and patient selection. [2022]
Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. [2019]
Selective intraarterial radionuclide therapy with Yttrium-90 (Y-90) microspheres for hepatic neuroendocrine metastases: initial experience at a single center. [2019]
Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study. [2022]
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