Assessment of microbiological monitoring for the evaluation of GMP-compliance at a department of Nuclear Medicine and Molecular Imaging of the University Medical Center Groningen

Objective: The purpose of our study was to assess trends and deviations from microbiological monitoring in De cleanroom facilities at the department of Nuclear Medicine and Molecular Imaging of the University Medical Center Groningen over the past five years. This was done to evaluate the status of GMP compliance. Methods: Data from active air sampling, passive air sampling, particle counting and contact prints from microbiological monitoring performed over the past five years were collected from our data bases. These tests are carried out routinely to comply with the applicable GMP-regulations. The data were retrospectively analyzed by counting the number of measurements and calculating the number of crossings of the set limit for each sampling location and each test. Statistical analysis was done by performing a Fisher's exact test (P 5 times decrease of limit crossings) and were statistically significant (

Biodistribution of Zr-89-trastuzumab and PET Imaging of HER2-Positive Lesions in Patients With Metastatic Breast Cancer

We performed a feasibility study to determine the optimal dosage and time of administration of the monoclonal antibody zirconium-89 (Zr-89)-trastuzumab to enable positron emission tomography (PET) imaging of human epidermal growth factor receptor 2 (HER2)-positive lesions. Fourteen patients with HER2-positive metastatic breast cancer received 37 MBq of Zr-89-trastuzumab at one of three doses (10 or 50 mg for those who were trastuzumab-naive and 10 mg for those who were already on trastuzumab treatment). The patients underwent at least two PET scans between days 2 and 5. The results of the study showed that the best time for assessment of Zr-89-trastuzumab uptake by tumors was 4-5 days after the injection. For optimal PET-scan results, trastuzumab-naive patients required a 50 mg dose of Zr-89-trastuzumab, and patients already on trastuzumab treatment required a 10 mg dose. The accumulation of Zr-89-trastuzumab in lesions allowed PET imaging of most of the known lesions and some that had been undetected earlier. The relative uptake values (RUVs) (mean +/- SEM) were 12.8 +/- 5.8, 4.1 +/- 1.6, and 3.5 +/- 4.2 in liver, bone, and brain lesions, respectively, and 5.9 +/- 2.4, 2.8 +/- 0.7, 4.0 +/- 0.7, and 0.20 +/- 0.1 in normal liver, spleen, kidneys, and brain tissue, respectively. PET scanning after administration of Zr-89-trastuzumab at appropriate doses allows visualization and quantification of uptake in HER2-positive lesions in patients with metastatic breast cancer