← Back to Clinical Trials
Recruiting Phase 2 NCT03331601

Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients

Trial Parameters

Condition Carcinoma
Sponsor Universitair Ziekenhuis Brussel
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2017-10-16
Completion 2026-09
Interventions
68GaNOTA-Anti-HER2 VHH1

Brief Summary

This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included and the uptake in their lesions will be compared. Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.

Eligibility Criteria

Inclusion Criteria: * Patients who have given informed consent * Age 18 years or older * Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI. * Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose. Exclusion Criteria: * Pregnant patients * Breast feeding patients * Patients with recent (\< 1 week) gastrointestinal disorders with diarrhea as major symptom * Patients with any serious active infection * Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical * Patients who cannot communicate reliably with the investigator * Patients at increased risk of death from a pre-existing concurrent illness

Related Trials