Clinical trial NCT04315883: Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors
Official title: Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Alfred I. duPont Hospital for Children
First posted: 2020-03-20
Enrollment: 3
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric and Young adult patients with liver tumors

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. 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
timeFrame: Assessed at baseline/time of treatment
measure: Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
timeFrame: Assessed at 1 month post therapy
measure: Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
timeFrame: Assessed at 6 months post therapy
measure: Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
timeFrame: Assessed at 12 months post therapy
measure: Determine the impact of TARE-Y90 treatment on health related quality of life (HRQOL)
timeFrame: Assessed at 5 years post therapy
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining 2 year survival
timeFrame: Patients will be assessed at 2 years post therapy
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining 5 year survival
timeFrame: Patients will be assessed at 5 years post therapy
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining local tumor response
timeFrame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining resection rate
timeFrame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining Transplant rate
timeFrame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining histologic response
timeFrame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining biologic response
timeFrame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
measure: Evaluate the efficacy and clinical utility of TARE-Y90 by examining clinical course
timeFrame: Patients will be assessed at the end of treatment which is typically 2-4 months following treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours-AI duPont Hospital for Children
state: Delaware
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
Study officials:
affiliation: Nemours
name: Howard Katzenstein
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.