Image

SEGWAY(Short-term Embolization Using Gelatin Particles for floW modulAtion During Y90 Radioembolization)

SEGWAY(Short-term Embolization Using Gelatin Particles for floW modulAtion During Y90 Radioembolization)

Recruiting
19 years and older
All
Phase N/A

Powered by AI

Overview

Short-acting coloration for normal liver protection in liver cancer patients undergoing radioembolization therapy a study on the effectiveness of all substances

Description

Patients' liver function can be preserved when delivery of radioembolic agents to the non-tumorous liver is minimized. This is a single-center, single-arm clinical trial to evaluate the efficacy of short-acting embolization particles to temporarily embolize the hepatic arteries toward the non-tumorous liver in patients with hepatocellular carcinoma treated by radioembolization of a large perfused volume. A transient embolic effect will be evaluated by digital subtraction angiography during the procedure. Absorbed doses of the transiently protected non-tumorous liver and unprotected non-tumorous liver will be compared by pre-treatment SPECT-CT (99mTc injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization). In addition, liver volume and function changes for six months will be estimated using gadoxetic acid-enhanced dynamic MRI.

Eligibility

Inclusion Criteria:

  1. Age > 18-year-old
  2. Histologically or radiologically (LI-RADS 4 or 5) diagnosed as hepatocellular carcinoma
  3. Patients for whom radioembolization was determined as the optimal treatment after hepatologists', hepatic surgeons' or multidisciplinary clinics.
  4. Patients who have not undergone local treatments such as ablation or chemoembolization in the same lobe of the liver within the past year.
  5. Child-Pugh class A
  6. Eastern Cooperative Oncology Group performance status 0-2
  7. Planned perfused area including two or more Couinaud segments based on angiography
  8. Non-tumorous liver volume / total perfused area > 50%

Exclusion Criteria:

  1. Hepatocellular carcinoma with vascular invasion on diagnostic imaging
  2. History of active cancer other than hepatocellular carcinoma within recent two years
  3. Surgical anastomosis of the bile duct and bowel
  4. Lung shunt fraction ≥ 15% on 99mTc- macroaggregated albumin lung scan
  5. Patients contraindicated to gelatin

Study details
    Liver Cancer (Primary and Metastatic)

NCT06229080

Next Biomedical Co., Ltd.

25 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.