MedTrace Logo

Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study

NCT02067988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-06-17

No results posted yet for this study

Summary

Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an interventional, treatment, non-randomized, open label, non-comparative, phase II study. 166Ho-RE will be performed via a catheter during angiography.

Conditions

Interventions

DEVICE

Holmium-166 microspheres hepatic radioembolization.

Holmium-166 microspheres hepatic radioembolization.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Marnix G Lam, MD, PhD · UMC Utrecht, The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • Netherlands

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 NCT02067988 on ClinicalTrials.gov