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

NCT04315883 | Terminated

• 1 other identifier: NEMOURS TARE-Y90: ST1901
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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. 1.the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
2. 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

Keywords

Hepatoblastoma; Hepatocellular carcinoma; Rhabdoid tumor of the liver; Undifferentiated sarcoma of the liver; Liver transplant; unresectable; yttrium 90; Y90; radioembolization; resection; pediatric; cancer; liver tumor

Outcome Measures

Primary Outcomes (13)

• Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)

  Evaluation of change of HRQOL survey responses will be performed: -at baseline (time of treatment) The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

  Assessed at baseline/time of treatment

• Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)

  Evaluation of change of HRQOL survey responses will be performed: \- 1 month post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

  Assessed at 1 month post therapy

• Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)

  Evaluation of change of HRQOL survey responses will be performed: \- 6 months post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

  Assessed at 6 months post therapy

• Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)

  Evaluation of change of HRQOL survey responses will be performed: \- 12 months post treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

  Assessed at 12 months post therapy

• Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)

  Evaluation of change of HRQOL survey responses will be performed: \- 5 years post-treatment The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

  Assessed at 5 years post therapy

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining 2 year survival

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic \-

  Patients will be assessed at 2 years post therapy

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining 5 year survival

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

  Patients will be assessed at 5 years post therapy

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining local tumor response

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -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).

  Patients will be assessed at the end of treatment which is typically 2-4 months following treatment

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining resection rate

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Resection Rate following treatment

  Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining Transplant rate

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Transplant Rate following treatment

  Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining histologic response

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant

  Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining biologic response

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors

  Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.

• Evaluate the efficacy and clinical utility of TARE-Y90 by examining clinical course

  Deliver catheter directed yttrium-90 directly to liver tumors and assess -Review of clinical course post-treatment-rehospitalization rate

  Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.

Study Arms (1)

Standard Treatment

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

Behavioral: Quality of Life Assessment; Radiation: Transarterial Radioembolization

Interventions

Quality of Life Assessment BEHAVIORAL

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

Standard Treatment

Transarterial Radioembolization RADIATION

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

Standard Treatment

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric and Young adult patients with liver tumors

You may qualify if:

• Boys and girls age \< 21 years of age
• History of liver tumor
• Meet criteria for treatment with TARE-Y90

You may not qualify if:

• Inability to complete required study procedures.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Alfred I. duPont Hospital for Children: collaborator

Study Sites (2)

Nemours-AI duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

Related Publications (1)

• Aguado A, Ristagno R, Towbin AJ, Gupta A, Haberle S, Qi Z, Patel MN, Kukreja KU, Tiao GM, Geller JI. Transarterial radioembolization with yttrium-90 of unresectable primary hepatic malignancy in children. Pediatr Blood Cancer. 2019 Jul;66(7):e27510. doi: 10.1002/pbc.27510. Epub 2018 Nov 8.

  PMID: 30406959 RESULT

MeSH Terms

Conditions

Hepatoblastoma; Carcinoma, Hepatocellular; Disorders of Sex Development; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Howard Katzenstein

  Nemours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 20, 2020
• Study Start: February 11, 2021
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)