Radiopharmaceutical Manufacturing

Radiopharmaceutical Manufacturing

The Edmonton PET Centre has a suite of GMP labs for the manufacturing and
quality control of all clinically used PET radiopharmaceuticals.

Clinical PET Radiopharmaceuticals

The following radiopharmaceuticals are used at the Edmonton PET Centre to assess and manage the treatments of our cancer patients:

  • FDG (fluorodeoxyglucose)

    PET scanning with the tracer (18F) fluorodeoxyglucose (FDG, FDG-PET) is widely used in clinical oncology. This tracer mimics glucose and is taken up and retained by tissues with high metabolic activity, such as the brain, the liver, and most types of malignant tumour. As a result FDG-PET can be used for diagnosis, staging, and monitoring treatment of cancers. Oncology scans using FDG make up over 90% of all PET scans in current practice. Our FluGlucoScan (FDG) monographs are located here.

  • FAZA (fluoroazomycin arabinoside)

    Hypoxia (virtual absence of O2) is a prognostic feature associated with an aggressive clinical and biological phenotype and develops as a result of transient capillary occlusion, vascular or arterial damage, or inadequate angiogenesis in a wide range of clinical disorders. The hypoxic microenvironment within tumors poses high resistance to X-ray therapy and promotes both local invasion and distant metastasis, thereby, contributing to the failure of external beam radiotherapy (XRT).

    1-&#945-D-(5-Deoxy-5-[18F]fluoroarabinofuranosyl)-2-nitroimidazole ([18F]FAZA), a PET radiotracer that selectively accumulates in hypoxic cells, was developed at the Cross Cancer Institute1, Edmonton, and is currently used in several medical centres to assess tumor hypoxia in cancer patients.2-4 The hypoxia specific uptake of FAZA is attributable to organ perfusion, its diffusion through cell membranes, reductive binding, and rapid clearance from non-hypoxic (i.e. non-target) regions of the body.5 [18F]FAZA shows improved tracer pharmacokinetics in comparison to other ‘first generation’ clinical hypoxia PET tracers such as fluoromisonidazole [18F]FMISO and [123I]IAZA, and has an advantage of higher tissue perfusion and more rapid clearance from blood, to produce higher hypoxia (tissue) : blood ratios and, therefore, better visualization of hypoxic tissue.6 [18F]FAZA is being manufactured under GMP guidelines at Edmonton PET Centre. Phase I clinical trial is complete now and phase II studies have started under Health Canada guidelines in CCI, Edmonton in the patients with known squamous cell carcinoma of the head & neck, small cell & non-small cell carcinoma of the lung, lymphoma or glioblastoma multiforme.

    References:
    1. Kumar P, D Stypinski, H Xia, AJB McEwan, H-J Machulla, LI Wiebe. Fluoroazomycin arabinoside (FAZA): Synthesis, 2H and 3H-labelling and preliminary biological evaluation of a novel-2-nitroimidazole marker of tissue hypoxia. J. Label. Comp. Radiopharmaceuticals. 42, 3-16 (1999).
    2. Souvatzoglou, B Roeper, A Grosu, H-J Machulla, P Maria, R Beck, LI Wiebe, M Molls, M Schwaiger, M Piert. Tumor hypoxia imaging with 18F-FAZA in head and neck cancer: a pilot study. J Nucl Med, Abstract Book Suppl, #124 (2005).
    3. Hicks, R. Unpublished.
    4. Machulla, R. Unpublished.
    5. Sorger D, M Patt, P Kumar, LI Wiebe, H Barthel, A Seese, C Dannenberg, A Tannapfel, R Kluge, O Sabri. Comparison of [18F]Fluoroazomycinarabinoside ([18F]FAZA) and [18F]Fluoromisonidazole ([18F]FMISO) as hypoxia tracers: quantitative cell culture studies and PET imaging of experimental rat tumors. Nucl. Med. Biol. 30, 317-326 (2003).
    6. Piert M, H-J Machulla, M Picchio, G Reischl, S Ziegler, P Kumar, H-J Wester, R Beck, AJB McEwan, LI Wiebe, M Schwaiger. Hypoxia-specific Tumor Imaging with Fluorine-18 Labeled Fluoroazomycin Arabinoside ([18F]FAZA). J Nucl Med. 46, 106-113 (2005).

     

  • FES (fluoroestradiol)

    [18F] 16{alpha}-fluoroestradiol (FES) is a PET imaging agent useful for the study of estrogen receptors in breast cancer. It may be used to predict which patients with advanced breast cancer will be resistant to and which will do well with hormonal therapy. FES is an estrogen analog that binds to estrogen receptors (ERs) in ER-positive breast cancer.

  • FLT (fluorothymidine)

  • C11 (choline)