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A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

NCT03295006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 209

Last updated 2021-04-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

TheraSphere

Patients who had received TheraSphere

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Marnix Lam, MD, PhD · Universitair Medisch Centrum Utrecht

  • Riad Salem, MD · Northwestern University

  • Etienne Garin, MD · Centre Eugène Marquis

  • Hugo de Jong, PhD · Universitair Medisch Centrum Utrecht

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Netherlands
  • Saudi Arabia
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03295006 on ClinicalTrials.gov