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.

This prospective study will utilize investigational PET acquisitions on the newly available
digital photon counting detector platform to develop and optimize PET acquisition and
postprocessing techniques as well as to generate preliminary and comparative data for
potential confirmatory clinical trials. The investigators will assess these innovations in
regard but not limited to visual inspection of lesions, normal tissue, sentinel nodes and
imaging artifacts, semi-quantitative and blinded reader analysis. The PET methodologies that
are planned to be used as part of this study will allow the investigators to obtain
morphological, functional and molecular information in ways beyond any current standard of
care imaging procedures.

Patients are anticipated to be recruited from 3 general populations. 1 - Patients enrolled in
a clinical trial where innovative PET imaging may be beneficial to the trial, although not
necessarily the individual patient. This would include patients enrolled in a clinical trial
exploring a new treatment approach for whom imaging at other timepoints in treatment would
not be covered by insurance and therefore not considered standard of care (SOC). 2 - Any
patient with a concern for a medical condition / question not yet fully resolved by SOC
practice for whom a treating physician believes that a research PET may have a potential to
address the medical question and help for future patients with similar questions. For
example, this could include a patient presenting with heel pain for whom standard x-ray shows
no confirmation of injury, but the physician feels an innovative PET bone scan could help
identify the cause of the pain. 3 - Any patient having a SOC PET scan who would be interested
in receiving an investigational scan, either as part of or in addition to the SOC scan. This
would include patients already scheduled for a SOC scan who would be willing to have an
investigational PET acquisition immediately following the standard acquisition for example
acquired with a shorter scan time. This would also include patients who have already had a
SOC PET examination, but would be willing to have a second, investigational PET exam, with a
significantly reduced radiotracer dose for example.Thus the radiation dose and exposure
associated with the investigational imaging would be in addition to any standard of care
imaging, although the two will be combined whenever appropriate.

Patients will be asked to provide study personnel with authorization to access their medical
records for follow-up on future related procedures as well as the current outcome of their
standard of care imaging. Additionally, participants will be asked if their imaging data from
this study can be used in a de-identified manner in the future for comparison with other
imaging data or as preliminary data for the protocol development of clinical trials.

Inclusion Criteria:

- Male and female volunteers greater than or equal to 18 years of age having a medical
diagnosis which justifies exploratory PET imaging

Exclusion Criteria:

- Participants who are pregnant or lactating

- Prisoners

- Subjects incapable of giving informed written consent or who are unlikely to complete
the imaging procedure