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

NCT ID: NCT04518748

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2028-11-30

Brief 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.

Detailed 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.

Updated to add 5 patients to enrollment goal to achieve desired number of evaluable patients

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.

Conditions

Liver Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Y-90 SIRT followed by SBRT

Y-90 SIRT followed by SBRT

Group Type: EXPERIMENTAL

Yttrium-90

Intervention Type: DRUG

Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)

Selective Internal Radiation Therapy

Intervention Type: DEVICE

SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

3-5 fractions over 1-2 weeks, after Y-90 SIRT

PET/CT

Intervention Type: DIAGNOSTIC_TEST

Within 3 hours of completing Y-90 SIRT

Therasphere

Intervention Type: DEVICE

Glass microspheres containing Y-90, administered at day 0 by SIRT

Interventions

Yttrium-90

Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)

Intervention Type: DRUG

Selective Internal Radiation Therapy

SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres

Intervention Type: DEVICE

Stereotactic Body Radiation Therapy

3-5 fractions over 1-2 weeks, after Y-90 SIRT

Intervention Type: RADIATION

PET/CT

Within 3 hours of completing Y-90 SIRT

Intervention Type: DIAGNOSTIC_TEST

Therasphere

Glass microspheres containing Y-90, administered at day 0 by SIRT

Intervention Type: DEVICE

Other Intervention Names

Y-90; SIRT; SBRT

Eligibility Criteria

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 effective contraception throughout the study and for 90 days following treatment.
• Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

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 of reproduction.
• Patients with known allergy or contraindication to intravenous iodinated contrast agents
• Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)
• Contraindication to Theraspheres

• Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
• Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.
• Hepatic artery catheterization contraindication; such as patients with vascular abnormalities 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 SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Cuneo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cancer AnswerLine

Role: CONTACT

CancerAnswerLine@med.umich.edu

1-800-865-1125

Facility Contacts

Kyle Cuneo, MD

Role: primary

kcuneo@med.umich.edu

734-355-5639

Other Identifiers

HUM00181352

Identifier Type: OTHER

Identifier Source: secondary_id

R01EB022075

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2020.052

Identifier Type: -

Identifier Source: org_study_id