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HEPAR Primary: Holmium-166-radioembolization in Hepatocellular Carcinoma Patients

NCT03379844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-08

No results posted yet for this study

Summary

Patients with hepatocellular carcinoma often die from intrahepatic disease since current treatment options are generally limited. Local treatment using holmium radioembolization could offer an effective treatment and a more personal approach than yttrium radioembolization (standard-of-care) as holmium has more imaging options.

Conditions

Interventions

DEVICE

Holmium-166 radioembolization

An intra-arterial radioembolization procedure will be performed. The hepatic artery catheter is inserted via the femoral or radial artery under x-ray guidance by a trained interventional radiologist. The radiologist must repeatedly check the position of the catheter during the procedure to ensure it remains correctly sited and that reflux of the QuiremSpheres® into other organs does not occur. This is performed by injecting contrast medium. At the conclusion of the procedure, the catheter is removed.

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Quirem Medical B.V.

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Marnix G. Lam, MD, PhD · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2020-01-01
Completion
2021-08-01

Countries

  • Netherlands

Study Locations

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Diseases
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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 NCT03379844 on ClinicalTrials.gov