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

The goals of this study are to (1) develop and refine PET post-processing acquisition procedures, (2) generate preliminary and comparative imaging data for potential clinical trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by comparison with investigational PET imaging acquisitions.

Study Overview

• Status: Active, not recruiting
• Conditions: PET Imaging
• Intervention / Treatment: Diagnostic test: PET scan; Other: Retrospective data analysis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective population	Diagnostic test: PET scan; Investigational PET scan as add-on to standard-of-care scan
Experimental: Retrospective population	Other: Retrospective data analysis; Review of pre-existing data from January 1, 2001 through December 5, 2017

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image quality	assessed by blinded readers	through study completion, on average 2-5 years
artifacts	assessed by blinded readers	through study completion, on average 2-5 years
lesion detectability	assessed by blinded readers	through study completion, on average 2-5 years
image noise	assessed region of interest over target tissue and background	through study completion, on average 2-5 years

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2015
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RP0689/2013H0280

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes