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

NCT04518748 | Recruiting Phase 1 FDA Drug FDA Device

• 3 other identifiers: UMCC 2020.052HUM00181352R01EB022075
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Malignancy

Keywords

Ytrium-90 (Y-90); Selective Internal Radiation Therapy (SIRT); Stereotactic Body Radiation Therapy (SBRT)

Outcome Measures

Primary Outcomes (3)

• Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline

  The primary safety endpoint is the binary indicator for a CTP increase of 2 or more points within 6 months and relative to pre-SBRT baseline. An increase of 2 or more points indicates clinically significant liver decompensation.

  Up to 6 months after SBRT

• Incidence of toxicities of grade 3 or higher

  A secondary safety endpoint is grade 3+ toxicity within 6 months relative to pre-SBRT baseline. Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  Up to 6 months after SBRT

• Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5

  A secondary safety endpoint is the binary indicator for an increase in ALBI within 6 months relative to pre-SBRT baseline of 0.5 or greater.

  Up to 6 months after SBRT

Secondary Outcomes (4)

• Freedom from local progression (FFLP) at the lesion level

  Until progression or last surveillance scan at approximately 24 months after SBRT

• Freedom from local progression (FFLP) at patient level

  Until progression or last surveillance scan at approximately 24 months after SBRT

• Response rate

  Up to 6 months after SBRT

• Overall survival

  Until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years.

Study Arms (1)

Y-90 SIRT followed by SBRT

EXPERIMENTAL

Y-90 SIRT followed by SBRT

Drug: Yttrium-90; Device: Selective Internal Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy; Diagnostic Test: PET/CT; Device: Therasphere

Interventions

Yttrium-90 DRUG

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

Also known as: Y-90

Y-90 SIRT followed by SBRT

Selective Internal Radiation Therapy DEVICE

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

Also known as: SIRT

Y-90 SIRT followed by SBRT

Stereotactic Body Radiation Therapy RADIATION

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

Also known as: SBRT

Y-90 SIRT followed by SBRT

PET/CT DIAGNOSTIC_TEST

Within 3 hours of completing Y-90 SIRT

Y-90 SIRT followed by SBRT

Therasphere DEVICE

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

Y-90 SIRT followed by SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Department of Health and Human Services: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Yttrium-90; Radiosurgery; Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kyle Cuneo, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 19, 2020
• Study Start: September 16, 2020
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)