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89Zr-girentuximab ) Dosimetry in CCRC Study - ZIR-DOSE

NCT03556046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-04-01

No results posted yet for this study

Summary

The study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Cancer treatment will not be delayed by study participation.

Conditions

  • Clear Cell Renal Carcinoma

Interventions

DIAGNOSTIC_TEST

89Zr-Girentuximab

Single diagnostic injection on Day 0, followed by diagnostic scans on Days 3 and 7±1, as well as the whole body dosimetric imaging on Days 0, 1, 3 and 7±1

Sponsors & Collaborators

  • ABX CRO

    collaborator OTHER

  • Telix Pharmaceuticals (Innovations) Pty Limited

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Michael Tapner · ABX CRO

  • Peter F. A. Mulders, Prof. · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2018-12-17
Completion
2018-12-17

Countries

  • Netherlands

Study Locations

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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 NCT03556046 on ClinicalTrials.gov