Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study

NCT ID: NCT02685631

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1653 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. The principal objective of the RESIN registry is to evaluate response to therapy using objective response criteria such as modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of the Liver (EASL). The response criteria used will depend on tumor type treated and local policies as this is a registry and not a formal research study. Secondary criteria include overall survival, time to progression (TTP) and toxicity.

OUTLINE:

Patients receiving Yttrium Y90 resin microspheres treatment as part of their overall oncologic management are added in the RESIN registry database to collect and document information including: patient demographics (gender/age), previous oncologic treatments, details of Yttrium Y90 resin microspheres treatment, and to track outcomes and complications.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Localized Non-Resectable Adult Liver Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational/data registry collection

Patients receiving Yttrium-90 resin microspheres as part of care

Yttrium-90 Resin Microspheres

Intervention Type OTHER

Data collection into the RESIN registry

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yttrium-90 Resin Microspheres

Data collection into the RESIN registry

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients receiving SIR-Spheres therapy to the liver for the first time.
* Provision of written informed consent.
* Age 18 and older.

Exclusion Criteria

1. 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.
2. Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel B. Brown

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Brown

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University/Ingram Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama

Birmingham, Alabama, United States

Site Status

University of Arizona Health Sciences

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

University of Colorado, Denver

Denver, Colorado, United States

Site Status

Sky Ridge Medical Center

Englewood, Colorado, United States

Site Status

Christiana Care Health System

Wilmington, Delaware, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Cancer Treatment Centers of America

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Northwell Health- Lenox Hill Hospital

New York, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Wake Forest Medical Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Penn State Health Saint Joseph Medical Center

Reading, Pennsylvania, United States

Site Status

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, United States

Site Status

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Methodist Health System

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

The University of Utah

Salt Lake City, Utah, United States

Site Status

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39009301 (View on PubMed)

Emmons 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.

Reference Type DERIVED
PMID: 35762890 (View on PubMed)

Wong 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.

Reference Type DERIVED
PMID: 35232410 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2015-01837

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC GI 1523

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICCGI1523

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.