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

June 10, 2024 updated by: 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours-AI duPont Hospital for Children
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Specialty Care

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nemours Children's Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alfred I. duPont Hospital for Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Howard Katzenstein, Nemours

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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