As Director of Clinical PET Radiopharmaceutical production, Sally Schwarz is involved in the production of PET radiopharmaceuticals for clinical and clinical research use. 

The cyclotron facility is licensed as a PET Nuclear Pharmacy and a Drug Distributor.  The facility has 3 cyclotrons, and produces a variety of short-lived radiopharmaceuticals labeled with O-15, C-11, N-13, and F-18 ranging in half-life from 2 minutes for O-15 to 110 minutes for F-18.

Clinical PET imaging is primarily performed for oncologic imaging utilizing F-18 fluoro-2-deoxyglucose (FDG), for diagnosis and staging of cancers such as breast, lung, and cervical.   Carbon-11 labeled acetate is also used in diagnosis of prostate cancer.  As the PET field has grown, the necessary oversight of the FDA has increased, mandating additional requirements for radiopharmaceutical standard operating procedures (SOP) and quality control (QC). The short-lived PET isotopes present a unique challenge for preparation and required pre-release QC.

A significant number of clinical research PET radiopharmaceuticals are also prepared in the cyclotron facility, such as O-15 labeled water and oxygen (oxygen metabolism), F-18 fluorothymidine (cellular metabolism), F-18 fluorodopa (Parkinsonism), and  C-11 acetate, palmitate and glucose (cardiac metabolism).  These radiotracers are prepared under the authority of the FDA regulated Radioactive Drug Research Committee (RDRC) which reviews the scientific protocol submissions from physician investigators.  Chemistry files documenting production, validation and quality control process are prepared as part of the protocol submissions

1. LaForest R, Dehdashti F, Lewis JS, Schwarz SW. Dosimetry of 60/61/62/64Cu-ATSM: a hypoxia imaging agent for PET. EJNM 2004.
2. Dence CS, Herrero P, Schwarz S, Mach R, Gropler, R., Welch M. Imaging myocardium enzymatic pathways with Carbon-11 radiotracers. Methods in Enzymology, 2004.
3. Anderson CJ, Dehdashti F, Cutler PD, Schwarz SW, Laforest R, Bass LA, Lewis JS, McCarthy DW. Copper-64 TETA-Octreotide as a PET imaging agent for patients with neuroendocrine tumors. JNM 2000, 42:213-221.
4. Lewis JS, Lewis MR, Cutler PD, Srinivasan A, Schmidt MA, Schwarz SW, Morris MM, Miller MJ, Anderson CJ. Radiotherapy and dosimetry of 64Cu-TETA-Tyr3-Octreotate in a Somatostatin Receptor-positive, Tumor-bearing Rat Model1. Clin Can Research 1999;5:3608-3616
5. Connett JM, Anderson CJ, Li-Wu G, Schwarz SW, Zinn KR, Rogers BE, Siegel BA, Philpott GW, Welch MJ: Radioimmuniotherapy with a 64Cu-labeled monoclonal antibody: a comparison with 67Cu. Proc Natl Acad Sci 1996; 93:6814-6818.
6. Anderson CJ, Schwarz SW, Connett JM, Cutler D, Guo LW, Germain CJ, Philpott GW, Zinn KR, Greiner DP, Meares CF, Welch MJ: Preparation, biodistribution and dosimetry of copper-64-labeled anti-colorectal carcinoma monoclonal antibody (MAb) fragments 1A3-f(ab')2. J Nucl Med 1995; 36:850-858.
7. Philpott GW, Schwarz SW, Anderson CJ, Dehdashti FD, Connett JM, Zinn KR, Meares CF, Cutler PD, Welch MJ, Siegel BA: RadioimmunoPET: detection of colorectal carcinoma by positron emission tomography with a 64Cu-labeled monoclonal antibody. J Nucl Med 1995; 36:1818-1824.
8. Cutler PD, Schwarz SW, Anderson CJ, et al: Dosimetry of 64Cu-labeled monoclonal antibody 1A3 as determined by PET imaging of the torso. J Nucl Med 1995; 36:2363-2371.