Assessment of Investigational Positron Emission Tomography and Post-Processing Procedures Performed as Add-ons to Standard of Care Imaging

The prospective portion of study will utilize investigational PET acquisitions in addition to
standard of care PET imaging to develop and optimize PET acquisition post-processing
techniques as well as to generate preliminary and comparative data for potential clinical
trials. These post-processing techniques include but are not limited to visual inspection of
lesions, normal tissue, sentinel nodes and imaging artifacts, semi-quantitative analysis
including the use of rating schemes, and using various published methods for image
post-processing. The PET methodologies we plan to use as part of this study will allow us to
obtain morphological, functional and molecular information. Patients receiving a standard of
care PET will be asked by study personnel if they are interested in undergoing additional
investigational acquisitions before or after their standard of care imaging. If the patient
agrees, he/she will remain on the same PET scanner for up to an additional 30 minutes while
more images are obtained. Each patient will be imaged for no longer than 2 hours (standard of
care imaging and additional investigational imaging). A routine clinical report will be
generated for the clinically indicated PET by a nuclear medicine physician. Once this routine
clinical PET scan is dictated and finalized, a study team member will obtain the report via
IHIS and manually remove all identifiers. This report is being obtained for comparative
purposes. All the data being compared will be coded using a unique study number. The
retrospective portion of this study will involve the review of pre-existing data from January
1, 2001 through December 5, 2017. The data to be reviewed/analyzed includes PET imaging data
that has been previously collected in the course of standard clinical care. The PET imaging
acquisitions obtained from the retrospective review will be utilized as a comparison to the
investigational images obtained during the prospective portion of this study. The criteria
that will be utilized to determine how the retrospective data will be utilized includes the
following parameters: type of imaging study, diagnosis, age in decades, gender, and
availability of data in the imaging archive.

Prospective Population:

Inclusion Criteria:

- Male and female volunteers greater than or equal to 18 years of age

- Patients receiving a standard of care PET scan at OSU

Exclusion Criteria:

- Participants who are pregnant or lactating

- Prisoners

- Subjects incapable of giving informed written consent

Retrospective Population:

Inclusion Criteria:

- Male and female patients greater than or equal to 18 years of age

- Patients who have previously received a standard of care PET scan at OSU

Exclusion Criteria: