Feasibility Assessment of Next-generation PET Technology and Procedures

The objectives of this study are:

1. To enable innovative PET imaging in association with a clinical trial to add potential future biomarker readouts for disease characterization and therapy management.
2. To generate preliminary and comparative imaging data for potential confirmatory clinical trials using innovative imaging timepoints, acquisition, dose, and timing approaches, and/or postprocessing procedures.
3. To explore digital PET imaging for new indications where PET is not currently considered a standard of care diagnostic procedure in order to be able to design future clinical trials.

PET imaging is increasingly being used as a diagnostic modality in cancer detection and staging, neuro-molecular assessment, cardiovascular-molecular imaging, physiological/musculoskeletal imaging, and response assessment. Additionally, PET imaging is utilized in the detection and assessment of inflammatory processes. Constant advances in detector technology, image acquisition, and post-processing approaches could lead to the increased utility of PET in many currently unmet clinical scenarios.

The investigators have already performed an intra-individual comparison trial demonstrating advanced capabilities of digital PET technology in regard to lesion detection, lesion characterization, quantification, duration of scan time, and reduction of radiation dose. The digital PET is now fully FDA approved, and in this trial the investigators need to generate preliminary data in order to design prospective clinical trials that allow the validation of a hypothesis. The investigators have demonstrated the safety of the system [now FDA approved] and the overall efficacy in relation to current clinical care practice standards; however, the technology enables the change of those standards for which the investigators need to demonstrate the clinical feasibility that they have either shown in pre-clinical PET imaging or via simulations.

This research focuses on evaluating the new capabilities of PET imaging which may be improved or enabled by a new generation of fully digital PET systems. In order to change clinical practice, the investigators need to first generate data on the potential capabilities of this major technology improvement. The investigators will be performing and evaluating investigational PET/CT imaging beyond the current standard of care practice. Prior studies by the study team have already performed comparisons between the new and current PET imaging; however, the digital PET studies were constrained by being performed as a comparison to standard of care. In this clinical trial, the investigators can conduct research studies at innovative time points or using innovative procedures currently not covered by insurance, such as repeat imaging prior to treatment or midway through treatment for replanning purposes or to find better quantitative readouts to improve diagnosis and disease management. The investigators intend to conduct PET imaging also for indications not typically covered by insurance, such as cardiac, neuro-related, or orthopedic/sports medicine indications. The investigators may also perform imaging with FDA approved radiotracers beyond their normal use (off-label) to explore the synergistic capabilities of the new generation of PET imaging.