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Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors

NCT04315883 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2024-06-12

No results posted yet for this study

Summary

This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults.

The purpose of this study is to evaluate:

1. the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
2. to assess the change in the patient's quality of life before, during and after treatment with TARE-Y90

Conditions

  • Hepatoblastoma
  • Hepatocellular Carcinoma
  • Rhabdoid Tumor of Liver
  • Undifferentiated (Embryonal) Sarcoma of the Liver
  • Pediatric Liver Cancer
  • Liver Tumors

Interventions

BEHAVIORAL

Quality of Life Assessment

Evaluation of change of HRQOL survey responses will be performed: * at baseline (time of treatment) and * 1 month post treatment * 6 months post treatment * 12 months post treatment * 5 years post-treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

RADIATION

Transarterial Radioembolization

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic * Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST). * Resection Rate following treatment * Transplant Rate following treatment * Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant * Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors * Review of clinical course post-treatment-rehospitalization rate

Sponsors & Collaborators

  • Alfred I. duPont Hospital for Children

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Howard Katzenstein · Nemours

Eligibility

Min Age
0 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2024-03-28
Completion
2024-03-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315883 on ClinicalTrials.gov