Study on Y-90 Treatment Response Using Transarterial Radioembolization for Liver Cancer

Sponsor: Thomas Jefferson University

Sponsor score: 0

ClinicalTrials ID:NCT07145801

This study is exploring a new way to check how well a treatment called transarterial radioembolization (TARE) works for liver cancer using a special type of ultrasound. The goal is to see if this method can help doctors better understand how the cancer is responding to treatment.

Patient Parameters

Program Overview

This study is looking at how well a special ultrasound, called contrast-enhanced ultrasound (CEUS), can show the effects of a treatment called transarterial radioembolization (TARE) on liver cancer. TARE is a treatment used for some patients with liver cancer, but it's often hard to tell how well it's working using regular scans like CT or MRI. This study will see if CEUS can provide clearer results sooner, which might help doctors decide on further treatments more quickly. The study will involve 30 patients who are scheduled to receive TARE for liver cancer and will take place over 18 months.

Description

In this study, patients with liver cancer who are scheduled to receive a treatment called transarterial radioembolization (TARE) will also have a special type of ultrasound called contrast-enhanced ultrasound (CEUS) to see how well the treatment is working. The study will involve 30 patients and will take place over 18 months.

Patients will have CEUS exams within two weeks of their regular CT or MRI scans, which are done 1-2 months and 4-6 months after TARE. The ultrasound will use two different contrast agents, Lumason and Sonazoid, to help show how the cancer is responding to treatment. The ultrasound will be done by a trained sonographer and will involve several steps to capture images of the liver and any tumors.

After the ultrasound, patients will be monitored for 30 minutes before going home. The images and data collected will help researchers understand if CEUS can provide better information about how well TARE is working compared to traditional scans.

Patients will be recruited from six major hospitals and will be contacted by the study coordinator to discuss participation. They will have time to consider the study and ask questions before deciding to join. If they agree, they will sign a consent form and participate in the study at Jefferson's center city campus.

The study will also look at whether there are differences in how well the ultrasound works based on patient demographics like sex, race, and ethnicity. This information will help tailor the imaging strategy to different patient groups.

The study is not considered a clinical trial by NIH standards because it does not change the treatment based on the ultrasound findings. Instead, it aims to gather information to improve future treatment assessments.

Eligibility Criteria

Inclusion Criteria

  • Scheduled for TARE therapy for liver cancer that can be seen on an ultrasound.
  • At least 18 years old.
  • Medically stable.
  • If female and of child-bearing age, must have a negative pregnancy test.
  • Must have signed an informed consent to participate in the study.

Exclusion Criteria

  • Medically unstable, seriously or terminally ill, or with an unpredictable clinical course.
  • Known allergies to the components of Lumason or Sonazoid.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University19107PhiladelphiaPennsylvania

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