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Completed No phase listed Observational

A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

ClinicalTrials.gov ID: NCT03295006

Public ClinicalTrials.gov record NCT03295006. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03295006
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
209 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 30, 2016
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update posted
Apr 20, 2021

2016 – 2020

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Stanford University Medical Center Stanford California 94305-5642
University of Florida College of Medicine Gainesville Florida 32610-0374
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center Chicago Illinois 60611-2927
Indiana University School of Medicine Indianapolis Indiana 46202
Washington University in St. Louis, School of Medicine Saint Louis Louisiana 63110
The University of Texas MD Anderson Cancer Center Houston Texas 77030-3722

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03295006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 20, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03295006 live on ClinicalTrials.gov.

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