Working… Menu

Evaluation of the Veriton SPECT/CT System

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. Identifier: NCT04722185
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Information provided by (Responsible Party):
Michael O'Connor, Mayo Clinic

Brief Summary:
The main purpose of this study is to evaluate a new type of gamma camera (the Veriton system) that provides a significant gain in system sensitivity and improved image quality compared to a conventional gamma camera that can achieve equal or better image quality than a standard SPECT/CT system.

Condition or disease Intervention/treatment Phase
Focus of Study is Comparison of 2 Types of Gamma Cameras Diagnostic Test: Veriton SPECT/CT Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: each patient will have 2 scans - one on a conventional system and one on the newer technology
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Veriton SPECT/CT System
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 2, 2022

Arm Intervention/treatment
Experimental: Evaluation of the Veriton SPECT/CT system
To determine if the Veriton system can achieve equal or better image quality than a standard SPECT/CT system.
Diagnostic Test: Veriton SPECT/CT
The Veriton system represents an FDA approved (510k cleared) new generation of SPECT/CT systems. It consists of 12 small gamma cameras arrayed in a circle around the patient, and is coupled to a 64-slice CT system.

Primary Outcome Measures :
  1. Image quality [ Time Frame: 1 year ]
    Assessment of relative image quality between the Veriton system and a conventional gamma camera as a function of the type of nuclear medicine exam.

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.

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

Inclusion Criteria:

  • Adults age 18 years or older.
  • Currently scheduled to undergo a nuclear medicine exam.

Exclusion Criteria:

  • Individuals under 18 years of age.
  • Unwilling/unable to sign an informed consent form.
  • Unable to lie on a Veriton imaging table for up to 40 minutes.

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 identifier (NCT number): NCT04722185

Layout table for location contacts
Contact: Kera Delaney 507-293-5660
Contact: Michael K O'Connor, PhD 15073190142

Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Michael K O'Connor         
Sponsors and Collaborators
Mayo Clinic
Layout table for investigator information
Principal Investigator: Michael K O'Connor, PhD Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Michael O'Connor, Principal Investigator, Mayo Clinic Identifier: NCT04722185    
Other Study ID Numbers: 20-001511
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes