Trial ID or NCT#

NCT03295006

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (Interventional Radiology) at the Stanford University Medical Center
David S. Wang, MD
David S. Wang, MD
Interventional radiologist, Radiologist, Minimally invasive surgeon, Diagnostic radiologist
Clinical Assistant Professor, Radiology

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CONTACT

SPECTRUM