Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

Last updated: November 4, 2024
Sponsor: University of Michigan Rogel Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Liver Cancer

Neoplasms

Treatment

Stereotactic Body Radiation Therapy

Yttrium-90

Selective Internal Radiation Therapy

Clinical Study ID

NCT04518748
UMCC 2020.052
HUM00181352
R01EB022075
  • Ages > 18
  • All Genders

Study Summary

This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer.Hepatocellular carcinoma is defined as having at least one of the following:

  • Biopsy proven hepatocellular carcinoma (HCC); or

  • A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria.

Metastatic liver cancer is defined as having:

o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease

  • Patients must not have known untreated or progressive disease outside of the liver

  • At least one lesion >2 cm diameter or 4 cc volume

  • Patients must have a life expectancy of at least 6 months.

  • Patients must be 18 years of age or older

  • All men, as well as women of childbearing potential, must agree to use effectivecontraception throughout the study and for 90 days following treatment.

  • Patients must understand and be willing to sign an informed consent form approvedfor this purpose by the Institutional Review Board (IRB) of the University ofMichigan Medical Center indicating that they are aware of the investigationalaspects of the treatment and the potential risks.

Exclusion

Exclusion Criteria:

  • Inability to lie still for imaging studies (e.g. PET/CT)

  • Pregnancy or nursing females or refusal to use birth control in patients capable ofreproduction.

  • Patients with known allergy or contraindication to intravenous iodinated contrastagents

  • Patients with an allergy or contraindication to MRI on MRI contrast (Eovist orGadolinium)

  • Contraindication to Theraspheres

  • Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphyshowing any deposition to the gastrointestinal tract that may not be correctedby angiographic techniques

  • Shunting of blood to the lungs that could result in delivery of greater than 30Gy to the lungs.

  • Hepatic artery catheterization contraindication; such as patients with vascularabnormalities or bleeding diathesis;

  • Bilirubin >2.0 at baseline

  • Occlusion of the main portal vein

  • Contraindication to radiation therapy

  • Note: Patients who have an increase in bilirubin >1.0 from the time of Y90 to SBRTor his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.

Study Design

Total Participants: 65
Treatment Group(s): 5
Primary Treatment: Stereotactic Body Radiation Therapy
Phase: 1
Study Start date:
September 16, 2020
Estimated Completion Date:
November 30, 2028

Study Description

Selective Internal Radiation Therapy (SIRT) is a technique where radiation is internally delivered to a tumor. In SIRT, small radioactive beads are deposited in the liver through a large blood vessel (hepatic artery). SIRT that uses the radioactive material Yttrium-90 is called Y-90 SIRT.

Stereotactic Body Radiation Therapy (SBRT) is a technique where radiation is externally delivered to a tumor. In SBRT, a machine produces a beam of radiation that targets the tumor from outside the body.

After receiving Y-90 SIRT, participants will be evaluated to estimate how much radiation was absorbed by their tumors during Y-90 SIRT. Y-90 PET-CT imaging will be used to help plan SBRT, which will target areas of tumors that did not receive as much radiation as expected during Y-90 SIRT.

Since patients treated with Y-90 for any liver malignancy can benefit from the Y-90+SBRT combined treatment approach we have decided to open up the protocol to all eligible patients and not HCC alone.

Connect with a study center

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.