Spots Global Cancer Trial Database for Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
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Trial Identification
Brief Title: Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
Official Title: A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
Study ID: NCT04736121
Interventions
Study Description
Brief Summary: The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).
Detailed Description: The investigation is a pivotal, prospective, multicenter, open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres. Up to 100 subjects will be treated (up to 150 consented) at up to 30 clinical sites in the United States. The population for this study includes patients diagnosed with HCC BCLC stage A, B1, B2, and C with maximal single lesion size of ≤ 8cm and who are not considered suitable for treatment by resection or eligible for ablation at time of study entry.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles - Ronald Reagan Medical Center, Los Angeles, California, United States
Providence Holy Cross Medical Center, Mission Hills, California, United States
Providence St. Joseph Hospital, Orange, California, United States
University of California Irvine, Orange, California, United States
Stanford University, Stanford, California, United States
Miami Cardiac and Vascular Institute at Baptist Hospital, Miami, Florida, United States
Sarasota Memorial Health Care System, Sarasota, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Columbia University CUIMC/NYPH, New York, New York, United States
University of North Carolina - Chapel Hill Medical Center, Chapel Hill, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Center CTO, Cincinnati, Ohio, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Hospital of the University Pennsylvania, Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Clinical Research Institute and Methodist Hospital, Dallas, Texas, United States
University of Texas Health Science Center at Houston, Houston, Texas, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
The University of Vermont Medical Center, Burlington, Vermont, United States
Inland Imaging, Spokane, Washington, United States
Contact Details
Name: Armeen Mahvash, M.D.
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: S. Cheenu Kappadath, Ph.D.
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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