Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer
NCT07436858 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-27
Summary
The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.
Conditions
- Lung Cancer (NSCLC)
- HER2 Expression
- HER2 Gene Mutation
Interventions
- DIAGNOSTIC_TEST
-
Blood sampling for pharmacokinetics
To assess the pharmacokinetics of ⁸⁹Zr-trastuzumab, the investigators collect blood samples at multiple time points following tracer administration. Samples are drawn at 10 minutes, 30 minutes, 1 hour, and 2 hours post-injection, and again on day 4 and day 7 post-injection.
- DIAGNOSTIC_TEST
-
PET imaging with ⁸⁹Zr-trastuzumab
Participants will receive one injection of ⁸⁹Zr-trastuzumab and undergo a PET/CT scan four days later.
Sponsors & Collaborators
-
The Netherlands Cancer Institute
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2030-06-01
- Completion
- 2030-06-01
Countries
- Netherlands
Study Locations
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