UTSW Translational Molecular Imaging Core

Overview of Services

The Translational Molecular Imaging Core (TMIC) enables advanced positron emission tomography (PET) imaging technologies for basic biomedical research, translational studies, and clinical trials by providing investigators on campus with existing, investigational, and novel radiotracers.
A comprehensive cyclotron and radiochemistry facility has become fully functional at UT Southwestern since 2015 under the auspices of institutional commitments and initial funding from the Cancer Prevention and Research Institute of Texas (CPRIT). The facility meets the FDA’s requirements for current good manufacturing practice (CGMP) production of PET radiopharmaceuticals for human use under 21 CFR Part 212 and the United States Pharmacopeia Chapter <823> (USP 823). Equipped with a GE PETtrace 880 cyclotron and ancillary instruments, the facility is now capable of producing six (6) radioisotopes (15O: t1/2 = 2 min; 13N: t1/2 = 10 min; 11C: t1/2 = 20.3 min; 18F: t1/2 = 110 min; 64Cu: t1/2 = 12.7 h; and 89Zr: t1/2 = 3.27 d)2 and over thirty (30) radiotracers in addition to the FDA approved ones including 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG). To date, the facility has i) obtained eight (8) Investigational New Drug (IND) approvals from FDA including [18F]fluorestrodiol (FES) for imaging estrogen receptor status in breast cancer patients, [1-11C]acetate, [18F]FLT, [18F]HX-4 for cancer hypoxia imaging, and 64CuCl2 for Wilson’s disease imaging, and 89Zr-DFO-Atezolizumab for cancer immunoPET imaging; ii) submitted two (2) Abbreviated New Drug Applications (ANDA; [18F]FDG) & [13N]NH3) to the FDA; and iii) obtained one (1) Institutional Radioactive Drug Research Committee (RDRC) application ([64Cu]CuCl2). In addition, the facility has completed the required validation runs for clinical production of [11C]PIB (beta-amyloid imaging), [18F]AV1451 (tau imaging), [11C]glutamine, and [11C]methionine and is poised to submit their IND applications. Of note, the facility has been qualified to participate in two (2) National Cancer Institute (NCI) sponsored ECOG-ACRIN clinical trials for metastatic breast cancer and Acute Myeloid Leukemia (AML)by providing [18F]FES and [18F]FLT on FDA’s IND approvals.

We have recently installed a GE Discovery MI 5-ring PET/CT system. Services for clinical PET/CT research include standardized clinical protocol development (collaboration with individual investigators), scanner accreditation meeting SNMMI, EANM ACR, ACRIN and NCI standards for clinical trials, regulatory compliance when investigational PET radiopharmaceuticals are administered to patients at the PET center, examination / monitoring of patients before, during and immediately after PET/CT scans, Case Report Form (CRF) completion, and PET image analysis (standard, novel markers and kinetic analysis).

The Siemens Inveon PET/CT Multimodality System (NE3.116) is a small animal PET/CT imaging scanner built on the Siemens Inveon acquisition architecture, which fully integrates PET and CT into a common data acquisition system for automatic transition between modes and seamless coordination of CT and PET data acquisition. It was purchased by UT Southwestern in 2008 to meet the demand for non-invasive, quantitative, and real-time imaging of molecular targets in biologically relevant rodent models. Recent accomplishments include the development and implementation of imaging protocols in a wide range of disease models (e.g., cancer, diabetes, metabolism, cardiotoxicity, neurodegenerative diseases, etc.) and the validation of novel imaging probe development, which ranges from small organic molecule to macromolecules including proteins and nanoparticles.

The small animal SPECT/CT service is provided to support the mission of the Translation Molecular Imaging Core. The service is pleased to offer research investigators non-invasive physiological imaging on the major organ systems or CT imaging in rodent preclinical models. This is achieved with a high resolution small animal NanoSPECT/CT Plus scanner. Currently, the scanner is housed in the Preclinical Nuclear Imaging laboratory within the department of Radiology and Advanced Imaging Research Center. Tracers used in the imaging sessions maybe commercially available clinical radiopharmaceuticals or investigator produced labeled nanoparticles, proteins or small molecules. The scanner is capable of imaging gamma emissions at submillimeter resolution with a very broad range of energies as low as 35 keV (I-125) to several hundreds keV (e.g. I-131). Cardiac and respiratory gating is available. Another purpose of the service is to provide a range of services necessary to support preclincal gamma ray imaging or preclinical CT imaging. All scans are performed with physiologic monitoring of animals. Services provided include consultation with imaging scientists and radiologists for study design, analysis of imaging studies, skilled animal handling, anesthesia, IV injections and housing of radioactive animals. Image analysis software includes packages available on the scanner and a pharmacokinetic modeling package.

Leadership

Xiankai Sun | Professor

Dana Mathews | Professor

Orhan Oz | Professor

Location and hours of operation

Links and Resources

1. Cyclotron Website

Contacts