Spots Global Cancer Trial Database for A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC
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Trial Identification
Brief Title: A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC
Official Title: A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment
Study ID: NCT03295006
Conditions
Interventions
Study Description
Brief Summary: This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.
Detailed Description: Recently published evidence indicates a correlation between yttrium-90 dose delivered to the tumor and normal tissue with safety and efficacy outcomes but there are no validated methods to consistently measure dose delivered to the tumor and normal tissue. In contrast to the standard clinical approach based on average dose to one target volume, this trial, sponsored by Biocompatibles UK, will explore an alternative two-compartment TheraSphere dosimetry methodology to calculate absorbed dose to tumor and normal tissue
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford University Medical Center, Stanford, California, United States
University of Florida College of Medicine, Gainesville, Florida, United States
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Indiana University School of Medicine, Indianapolis, Indiana, United States
Washington University in St. Louis, School of Medicine, Saint Louis, Louisiana, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Centre Eugene Marquis, Rennes, , France
Universitätsklinikum Essen, Essen, , Germany
Foundation IRCCS Istituto Nazionale Tumori, Milan, , Italy
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
King Faisal Hospital, Riyad, , Saudi Arabia
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Istanbul university Istanbul medical school, Fatih, , Turkey
Florence Nightingale, Şişli, , Turkey
Contact Details
Name: Marnix Lam, MD, PhD
Affiliation: Universitair Medisch Centrum Utrecht
Role: PRINCIPAL_INVESTIGATOR
Name: Riad Salem, MD
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
Name: Etienne Garin, MD
Affiliation: Centre Eugène Marquis
Role: PRINCIPAL_INVESTIGATOR
Name: Hugo de Jong, PhD
Affiliation: Universitair Medisch Centrum Utrecht
Role: PRINCIPAL_INVESTIGATOR
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