We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility Assessment of Next-generation PET Technology and Procedures

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: NCT03387618
Recruitment Status : Recruiting
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the feasibility of investigational Positron Emission Tomography (PET) imaging using the new generation digital detector PET technology for new procedures beyond the current standard of care.

Condition or disease Intervention/treatment
New-generation Digital PET/CT Imaging Diagnostic Test: Digital PET/CT imaging

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Assessment of Next-generation PET Technology and Procedures
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Investigational Scan
new-generation digital PET/CT imaging technology
Diagnostic Test: Digital PET/CT imaging
Next generation PET/CT imaging


Outcome Measures

Primary Outcome Measures :
  1. Image Quality [ Time Frame: through study completion, an average of 3 years ]
    Assessing the benefit of the new advanced PET technology to improve the capabilities of PET imaging

  2. Accelerated Acquisition Time [ Time Frame: through study completion, an average of 3 years ]
    The necessary time of the patient to be on the imaging system table/bed will be measured and reported. Currently, the common acquisition time is approximately 20 minutes. We explore to reduce imaging times to 5 or 10 minutes.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations

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): NCT03387618


Contacts
Contact: Michael V Knopp, MD, PhD 614-293-9998 knopp.16@osu.edu

Locations
United States, Ohio
Martha Morehouse Medical Plaza Recruiting
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp, MD, PhD    614-293-9998    knopp.16@osu.edu   
Principal Investigator: Michael V Knopp, MD, PhD         
Sub-Investigator: Katherine M Binzel, PhD         
Sub-Investigator: Jun Zhang, PhD         
Sub-Investigator: Chadwick L Wright, MD, PhD         
Sponsors and Collaborators
Ohio State University
Ohio Third Frontier
  Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:
Study Protocol  [PDF] October 27, 2017
Informed Consent Form  [PDF] October 27, 2017

More Information

Responsible Party: Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03387618     History of Changes
Other Study ID Numbers: 2017H0119/RP0506
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes