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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2029
  • participants needed
    15
  • sponsor
    Nemours Children's Clinic
Updated on 3 March 2022
biologic agent
tumor markers
hepatoma
radioembolization
liver tumor

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

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

Details
Condition Hepatoblastoma, Hepatocellular Carcinoma, Rhabdoid Tumor of Liver, Undifferentiated (Embryonal) Sarcoma of the Liver, Pediatric Liver Cancer, Liver Tumors
Treatment quality of life assessment, Transarterial Radioembolization
Clinical Study IdentifierNCT04315883
SponsorNemours Children's Clinic
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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