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

University of Michigan Rogel Cancer Center

Status and phase

Enrolling

Phase 1

Conditions

Liver Malignancy

Treatments

Diagnostic Test: PET/CT

Drug: Yttrium-90

Device: Therasphere

Radiation: Stereotactic Body Radiation Therapy

Device: Selective Internal Radiation Therapy

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

NIH

Identifiers

NCT04518748

UMCC 2020.052

R01EB022075 (U.S. NIH Grant/Contract)

HUM00181352 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.