Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study
RESiN
Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Study
4 other identifiers
observational
1,653
1 country
42
Brief Summary
This research registry studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 19, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedSeptember 5, 2021
September 1, 2021
5.2 years
December 19, 2015
September 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease
Response to treatment is the initial measure of treatment efficacy. This can be measured using objective criteria such as the modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of Liver Cancer (EASL) criteria depending on local policy and tumor type.
Up to 1 year after the first treatment
Secondary Outcomes (3)
Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures
Up to 1 year after the first treatment
Overall Survival
2 years
Time to Progression
2 years
Study Arms (1)
Observational/data registry collection
Patients receiving Yttrium-90 resin microspheres as part of care
Interventions
Data collection into the RESIN registry
Eligibility Criteria
Patients with primary and secondary liver cancer receiving SIR Spheres® microspheres (Y90 resin microspheres) treatment as part of their overall oncologic management
You may qualify if:
- Patients receiving SIR-Spheres therapy to the liver for the first time.
- Provision of written informed consent.
- Age 18 and older.
You may not qualify if:
- Prior completion of Y90 therapy to the liver (SIR-Spheres, TheraSpheres, or any other liver-targeted therapy involving the use of radiation-emitting spheres).
- Patients who have received Y90 treatment in the past and who are returning for another Y90 treatment are ineligible, even if new areas are being targeted.
- Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (42)
University of Alabama
Birmingham, Alabama, United States
University of Arizona Health Sciences
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado, Denver
Denver, Colorado, United States
Sky Ridge Medical Center
Englewood, Colorado, United States
Christiana Care Health System
Wilmington, Delaware, 19899, United States
Georgetown University
Washington D.C., District of Columbia, United States
Baptist Hospital of Miami
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cancer Treatment Centers of America
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Saint Louis University
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health- Lenox Hill Hospital
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Methodist Health System
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Related Publications (3)
Zhou W, Du L, Brown DB, Shah RP, Sze DY. Outcomes Analysis of Yttrium-90 Radioembolization for Tumors Other Than Metastatic Colorectal Cancer from the Radiation-Emitting SIR-Spheres in Nonresectable (RESiN) Registry. J Vasc Interv Radiol. 2024 Nov;35(11):1591-1600.e3. doi: 10.1016/j.jvir.2024.07.006. Epub 2024 Jul 14.
PMID: 39009301DERIVEDEmmons EC, Bishay S, Du L, Krebs H, Gandhi RT, Collins ZS, O'Hara R, Akhter NM, Wang EA, Grilli C, Brower JS, Peck SR, Petroziello M, Abdel Aal AK, Golzarian J, Kennedy AS, Matsuoka L, Sze DY, Brown DB. Survival and Toxicities after 90Y Transarterial Radioembolization of Metastatic Colorectal Cancer in the RESIN Registry. Radiology. 2022 Oct;305(1):228-236. doi: 10.1148/radiol.220387. Epub 2022 Jun 28.
PMID: 35762890DERIVEDWong TY, Zhang KS, Gandhi RT, Collins ZS, O'Hara R, Wang EA, Vaheesan K, Matsuoka L, Sze DY, Kennedy AS, Brown DB. Long-term outcomes following 90Y Radioembolization of neuroendocrine liver metastases: evaluation of the radiation-emitting SIR-spheres in non-resectable liver tumor (RESiN) registry. BMC Cancer. 2022 Mar 1;22(1):224. doi: 10.1186/s12885-022-09302-z.
PMID: 35232410DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Brown
Vanderbilt University/Ingram Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 19, 2015
First Posted
February 19, 2016
Study Start
July 1, 2015
Primary Completion
August 31, 2020
Study Completion
August 31, 2021
Last Updated
September 5, 2021
Record last verified: 2021-09