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

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03490812
Collaborator
(none)
700
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET scan
  • Other: Retrospective data analysis
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Investigational Positron Emission Tomography and Post-Processing Procedures Performed as Add-ons to Standard of Care Imaging
Actual Study Start Date :
Jan 2, 2015
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. image quality [through study completion, on average 2-5 years]

    assessed by blinded readers

  2. artifacts [through study completion, on average 2-5 years]

    assessed by blinded readers

  3. lesion detectability [through study completion, on average 2-5 years]

    assessed by blinded readers

  4. image noise [through study completion, on average 2-5 years]

    assessed region of interest over target tissue and background

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43221

Sponsors and Collaborators

  • Ohio State University

Investigators

  • Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier:
NCT03490812
Other Study ID Numbers:
  • RP0689/2013H0280
First Posted:
Apr 6, 2018
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
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

Study Results

No Results Posted as of Apr 19, 2022