Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Evaluate the efficacy and clinical utility of TARE-Y90 by examining 2 year survival
Study Overview
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:
- the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
- 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 -
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
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
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
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).
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
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
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
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
Secondary Outcomes
No secondary outcomes reported