Study on Finding the Best Radiation Dose for Y-90 Treatment in Liver Tumors

Sponsor: Northwestern University

Sponsor score: 0

ClinicalTrials ID:NCT07586046

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This clinical trial aims to determine the optimal amount of radiation needed to effectively treat liver tumors that cannot be removed by surgery or standard methods. The study uses Yttrium-90 (Y90) radiation to target and destroy cancerous areas in the liver.

Patient Parameters

Program Overview

The purpose of this study is to find out the best dose of Yttrium-90 (Y90) radiation to treat liver tumors that cannot be surgically removed. Y90 treatment involves delivering tiny radioactive beads directly to the blood vessels feeding the liver tumor. These beads release radiation that kills cancer cells from the inside, targeting the tumor precisely while sparing healthy liver tissue. The study will use advanced imaging techniques, like PET/CT and PET/MRI scans, to see how the radiation is distributed in the liver and how the liver responds over time. These scans help doctors understand the best way to use Y90 to treat liver cancer effectively and safely.

Description

In this study, doctors are using a treatment called Yttrium-90 (Y90) radiation segmentectomy to treat liver tumors. This involves injecting tiny radioactive beads into the blood vessels that supply the liver tumor. These beads release radiation that helps kill cancer cells right at the tumor site, allowing doctors to target the tumor precisely while keeping the rest of the liver healthy. However, the exact dose needed to completely destroy a tumor without harming healthy liver tissue is not yet known.

To find the best dose, the study will use special imaging techniques before and after treatment to see how the radiation spreads in the liver and how the liver reacts over time. These imaging tests include PET/CT or PET/MRI scans, which are standard medical tests. During these scans, a small amount of a safe radioactive substance is injected into a participant's vein to show where the Y90 beads are in the liver.

A PET/CT scan combines two types of imaging: the PET scan shows how the liver is functioning at a molecular level, while the CT scan provides detailed images of the liver's structure. Together, they give a clear picture of both the structure and activity within the liver. PET/MRI works similarly but uses magnetic fields and radio waves instead of x-rays, providing detailed images of soft tissues like the liver.

Participants will also have a liver MRI with dual contrast using Eovist and extracellular gadolinium, which are standard imaging procedures. MRI uses magnets and radio waves to take detailed pictures of the liver. Eovist is a special dye that highlights liver tissue and shows how well different parts of the liver are working. Extracellular gadolinium enhances blood vessels and tissues, providing additional information. This imaging helps doctors confirm whether the tumor area was completely treated.

The goal is to find the safest and most effective dose of radiation to fully treat cancer while preserving healthy liver tissue. This information may help doctors treat future patients more precisely and safely. Yttrium-90 and the imaging methods used in this study, including PET/CT, PET/MRI, and dual contrast MRI, are FDA-approved.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer types like hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease that cannot be removed by surgery.
  • Age 18 years or older.
  • Have Child-Pugh class A or B liver function.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function, including:
    • White blood cell count of at least 3,000/mcL.
    • Neutrophil count of at least 1,500/mcL.
    • Hemoglobin level of at least 9 g/dL.
    • Platelet count of at least 50,000/mcL.
    • Total bilirubin level of 3.0 mg/dL or less.
    • AST level of 100 U/L or less, ALT level of 120 U/L or less.
    • Creatinine level of 2.0 mg/dL or less or estimated GFR of 40 mL/min/1.73 m² or higher.
  • Able to undergo imaging and laboratory evaluations required by the study.
  • Able to understand and willing to sign a written informed consent document.

Exclusion Criteria

  • Cancer that has spread outside the liver.
  • Pregnant or breastfeeding individuals.
  • Tumors that need treatment in more than two liver segments.
  • Known allergy to gadolinium-based contrast agents.
  • Conditions that prevent MRI, like certain pacemakers or severe claustrophobia.
  • Blood clotting issues or unstable health that prevents angiographic procedures.
  • Prisoners or individuals under legal custody.
  • Adults unable to consent.
  • Individuals under 18 years of age.

Locations

FACILITYZIPCITYSTATE
Northwestern University60611ChicagoIllinois

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