Non Invasive Imaging of Cetuximab-Zirconium-89 Uptake With PET: a Phase I Trial in Stage IV Cancer
Toxicity will be scored twice a week from the day of first injection (day 0) up to day 14,
according to the CTCAE3.0 scoring system. As after 14 days, the activity of Zr89 is low
(four half-lives of Zr89 is 4 x 3.2 days = 12.8 days), no additional toxic effect is
expected. Blood sampling will be done weekly (haematology, liver and kidney function).
When in 0/3 patients a toxicity of grade 3 or more has occurred step 2 is considered safe.
If in 1/3 patients a grade 3 has occurred, 3 more patients will be included in this step. If
another grade 3 toxicity occurs in 1/3 patients, the study will be stopped. When at maximum
1/6 patients experience a grade 3 toxicity, this step will be considered safe. When step 2
is considered safe, the study is ended.
After the injection, visualization of all tumour sites will be analyzed by performing a
PET-CT scan on day 4, 5 and 6 post injection. An additional scan on day 3 or 7 is optional.*
At day 5 post injection a perfusion PET-CT will be performed.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Toxicity (CTCAE 3.0)
Dirk De Ruysscher, Dr.
Maastro Radiation Oncology
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Cetuximab-Zr.89 fase I