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A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies

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NCT05629689 · readout in 934 d

Sponsored by GE Healthcare (industry) · GEHC — their whole pipeline →.

Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Diagnostic
Enrollment
50estimated
Sites
2
Country
Netherlands

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-01-27actualWhen the study began enrolling
Primary completion2029-03-10estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-03-10estimatedThe whole study's end, after follow-up
First posted2022-11-29actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-11-17actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Malignant Solid Tumor
  • Oncology

Interventions

  • Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A
  • Diagnostic test: Dynamic and Static - PET/CT scan
  • Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part B
  • Diagnostic test: Static - PET/CT scan

Primary outcomes

what the primary-completion date above is the date OF
Part A: The incidence of AEs upon causality to the IMPs.
measured Part A: 7 days
Part A: The severity of AEs per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) upon causality to the IMPs.
measured Part A: 7 days
To evaluate the time-course changes in GEH200521 (18F) Injection uptake after immune-checkpoint inhibitor (ICI) treatment cycles compared to baseline.
measured Part B: 50 days

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