RECRUITING

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

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Conditions

Liver MalignancyYtrium-90 (Y-90)Selective Internal Radiation Therapy (SIRT)Stereotactic Body Radiation Therapy (SBRT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

Quick Facts

Study Start:2020-09-16
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04518748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following:
  2. * Biopsy proven hepatocellular carcinoma (HCC); or
  3. * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria.
  4. * Patients must not have known untreated or progressive disease outside of the liver
  5. * At least one lesion \>2 cm diameter or 4 cc volume
  6. * Patients must have a life expectancy of at least 6 months.
  7. * Patients must be 18 years of age or older
  8. * All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment.
  9. * 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.
  1. * Inability to lie still for imaging studies (e.g. PET/CT)
  2. * Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction.
  3. * Patients with known allergy or contraindication to intravenous iodinated contrast agents
  4. * Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)
  5. * Contraindication to Theraspheres
  6. * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
  7. * Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.
  8. * Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis;
  9. * Bilirubin \>2.0 at baseline
  10. * Occlusion of the main portal vein
  11. * Contraindication to radiation therapy
  12. * 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.

Contacts and Locations

Study Contact

Cancer AnswerLine
CONTACT
1-800-865-1125
CancerAnswerLine@med.umich.edu

Principal Investigator

Kyle Cuneo, MD
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Kyle Cuneo, MD, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-16
Study Completion Date2028-11

Study Record Updates

Study Start Date2020-09-16
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Liver Malignancy