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

May 1, 2023 updated by: Allison Aguado, Nemours Children's Clinic

Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Referral to Nemours Liver Tumor Program is made by the primary team (oncologist/surgeon).
  • Phone discussion between the Nemours Liver Tumor Program Team will occur with the referring team about the patient.
  • Phone call between the Nemours Liver Tumor Program Team and the family will occur prior to any visit to discuss the potential plan of care and the basics of the TARE-Y90 procedure and the Quality of Life surveys.

Review of medical records provided by referring institution will be done by the Nemours Liver Tumor Program Team including:

History, Scans-actual imaging required, Path report-slide submission required, Roadmaps, Labs, Other pertinent medical history and records

-Visit to Nemours/AI DuPont Children's Hospital for initial consultation will be arranged by the Nemours Liver Tumor Program Team.

The patient and family will meet with the team including:

Liver transplant surgeon (Dr Dunn), Interventional Radiologist (Dr Aguado), Social worker, Child life specialist, Pediatric oncologist (Dr Gresh - on site, Dr Katzenstein by telemedicine)

  • Attempt will be made to schedule the pre-planning angiogram as part of initial visit (2nd day of visit). The angiogram requires the following 3-4 hours (mapping of blood vessels in and around tumor - determines whether patient can receive Y90, Angiogram is done with the patient sedated and having been after midnight the night before, The patient is expected to be discharged on the same day of the angiogram- no admit is planned but occasionally the patient may need overnight observation to occur due to age of the patient or the length of the procedure.
  • Return to home.
  • Potential additional single cycle of chemotherapy may be given prior to return to Nemours for Y90.

All further Chemotherapy Care is coordinated with Nemours Liver Tumor oncologists

-A 2nd visit to AIDHC will occur for TARE-Y90 treatment: The procedure lasts about 2-3 hours. There is no planned admit but possible if any problems occur.

  • 2 weeks post procedure a phone call follow-up after treatment will occur with the Nemours team
  • 2 weeks post procedure the patient may resume chemotherapy when cleared by the Nemours team
  • 4-6 weeks post Y90 treatment - a repeat CT/MRI will be done as well as lab tests.
  • If possible, the CT/MRI to be done at AIDHC/Nemours but can be done locally if travel barriers exist.
  • If the tumor is now resectable, planning will be made for resection at AIDHC/Nemours.
  • Evaluation and change of HRQOL survey responses will be performed at baseline (time of treatment) and 1, 6, 12 months and 5 years post-treatment. These surveys will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours-AI duPont Hospital for Children
        • Contact:
        • Contact:
        • Principal Investigator:
          • Allison Aguado
        • Principal Investigator:
          • Stephen Dunn
    • Florida

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.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pediatric and Young adult patients with liver tumors

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • • Inability to complete required study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
Time Frame: Assessed at baseline/time of treatment

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)
Time Frame: Assessed at 1 month post therapy

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)
Time Frame: Assessed at 6 months post therapy

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)
Time Frame: Assessed at 12 months post therapy

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)
Time Frame: Assessed at 5 years post therapy

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
Time Frame: Patients will be assessed at 2 years post therapy

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
Time Frame: Patients will be assessed at 5 years post therapy
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
Time Frame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment

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

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

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

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

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

Alfred I. duPont Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Anticipated)

March 1, 2029

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEMOURS TARE-Y90: ST1901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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