Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).
  2. 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.
  3. Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational/data registry collection Patients receiving Yttrium-90 resin microspheres as part of care
  • Other: Yttrium-90 Resin Microspheres
    Data collection into the RESIN registry

Recruiting Locations

University of Alabama
Birmingham, Alabama
Contact:
Ripal Ahmed Kamel Abdel Aal, MD, PhD
205-934-6504

University of Arizona Health Sciences
Tucson, Arizona 85724

University of Arkansas for Medical Sciences
Little Rock, Arkansas
Contact:
James Meek, MD
501-686-8274

Cedars-Sinai Medical Center
Los Angeles, California
Contact:
Gabriel H Lipshutz, MD

California Pacific Medical Center
San Francisco, California
Contact:
Peter Gasper
415-600-3472
peter@cpmcri.org

University of California, San Francisco
San Francisco, California
Contact:
Curt Johanson
415-353-2310

Stanford University
Stanford, California

University of Colorado, Denver
Denver, Colorado
Contact:
Rebecca Guigli, BS, BA
720-848-6502
Rebecca.Guigli@ucdenver.edu

Sky Ridge Medical Center
Englewood, Colorado
Contact:
Alicia Drew, MSN, RN, CNL
720-493-3614
alicia.drew@riaco.com

Christiana Care Health System
Wilmington, Delaware 19899

Georgetown University
Washington, District of Columbia
Contact:
Alexander Y Kim, MD

Baptist Hospital of Miami
Miami, Florida
Contact:
Ripal Gandhi, MD
786-596-5590

University of Miami
Miami, Florida
Contact:
Robert Abrahams, DO
305-243-2474

Sarasota Memorial Hospital
Sarasota, Florida

Tampa General Hospital
Tampa, Florida

Cancer Treatment Centers of America
Atlanta, Georgia
Contact:
Holly Holmes, RN, BSN
770-400-6481
holly.holmes@ctca-hope.com

Emory University
Atlanta, Georgia

Piedmont Hospital
Atlanta, Georgia

University of Kansas Medical Center
Kansas City, Kansas
Contact:
Zachary Collins, MD
913-588-8685

Ochsner Clinic Foundation
New Orleans, Louisiana
Contact:
Amanda Struckhoff
504-842-3682
amanda.struckhoff@ochsner.org

University of Maryland School of Medicine
Baltimore, Maryland
Contact:
Lauren Spiller
410-328-3631
Lauren.Spiller-Holtzman@umm.edu

Massachusetts General Hospital
Boston, Massachusetts
Contact:
Suvranu Ganguli, MD
617-726-8314
sganguli@partners.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Andrew J Oliver, BA
612-624-4865
oliv0190@umn.edu

Saint Louis University
Saint Louis, Missouri
Contact:
Melissa Hance, MS, CCRP
314-268-5785
mmcconn4@slu.edu

Albany Medical Center
Albany, New York
Contact:
Gary Siskin, MD
518-262-5356

Roswell Park Cancer Institute
Buffalo, New York
Contact:
Shannon Peck, MD
877-275-7724

Northwell Health- Lenox Hill Hospital
New York, New York
Contact:
Allison C. O'Regan
212-434-3695
aoregan@northwell.edu

Carolinas Medical Center
Charlotte, North Carolina
Contact:
Eric Wang, MD

University Hospitals Cleveland Medical Center
Cleveland, Ohio
Contact:
F. Philipp W. Graner, MSc
216-844-8275

Oregon Health & Science University
Portland, Oregon
Contact:
Lori Russell, RN, CCRP
503-494-7226
watsonlo@ohsu.edu

University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania

Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania

Spartanburg Regional Healthcare System
Spartanburg, South Carolina
Contact:
Kyran Dowling, MD
864-560-6812
clinicaltrials@gibbscc.org

Sanford USD Medical Center
Sioux Falls, South Dakota
Contact:
605-312-0067

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Daniel B. Brown, MD
615-322-3906
daniel.b.brown@vanderbilt.edu

Methodist Health System
Dallas, Texas
Contact:
Islam Shahin, MD
214-947-4400

Houston Methodist Hospital
Houston, Texas
Contact:
Melissa Whipple, BSN, RN
713-441-3247
mbwhipple@houstonmethodist.org

The University of Utah
Salt Lake City, Utah
Contact:
CJ Arsenault, CCRP
801-587-8638
collin.arsenault@hsc.utah.edu

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington

More Details

NCT ID
NCT02685631
Status
Recruiting
Sponsor
Vanderbilt-Ingram Cancer Center

Study Contact

Vanderbilt-Ingram Service for Timely Access
800-811-8480

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.