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

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	0 Years - 21 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04315883
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nemours Children's Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Howard Katzenstein
Principal Investigator Affiliation	Nemours
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hepatoblastoma, Hepatocellular Carcinoma, Rhabdoid Tumor of Liver, Undifferentiated (Embryonal) Sarcoma of the Liver, Pediatric Liver Cancer, Liver Tumors

Additional Details

- 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

Arms & Interventions

Arms

: 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

Interventions

Behavioral: - Quality of Life Assessment

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nemours-AI duPont Hospital for Children, Wilmington, Delaware

Status

Recruiting

Address

Nemours-AI duPont Hospital for Children

Wilmington, Delaware, 19803

Site Contact

Howard Katzenstein

[email protected]

904-697-3793

Nemours Children's Specialty Care, Jacksonville, Florida

Status