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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490812
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Michael V. Knopp MD, PhD, Ohio State University

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
PET Imaging Diagnostic Test: PET scan Other: Retrospective data analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2, 2015
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. image quality [ Time Frame: through study completion, on average 2-5 years ]
    assessed by blinded readers

  2. artifacts [ Time Frame: through study completion, on average 2-5 years ]
    assessed by blinded readers

  3. lesion detectability [ Time Frame: through study completion, on average 2-5 years ]
    assessed by blinded readers

  4. image noise [ Time Frame: through study completion, on average 2-5 years ]
    assessed region of interest over target tissue and background



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490812


Contacts
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Contact: Melanie Hughes 614-293-9998 office@wcibmi.org
Contact: Michael V Knopp, MD, PhD 614-293-9998 knopp.16@osu.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp, MD, PhD    614-293-9998    knopp.16@osu.edu   
Sub-Investigator: Chadwick L Wright, MD, PhD         
Sub-Investigator: Jun Zhang, PhD         
Sub-Investigator: Subha V Raman, MD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Michael V Knopp, MD, PhD Ohio State University
  Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:
Study Protocol  [PDF] December 20, 2017


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Responsible Party: Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03490812    
Other Study ID Numbers: RP0689/2013H0280
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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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