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Evaluation of the Veriton SPECT/CT System

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ClinicalTrials.gov Identifier: NCT04722185
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
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

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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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT04722185


Contacts
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Contact: Kera Delaney 507-293-5660 Delaney.Kera@mayo.edu
Contact: Michael K O'Connor, PhD 15073190142 mkoconnor@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Michael K O'Connor         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael K O'Connor, PhD Mayo Clinic
Additional Information:
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Responsible Party: Michael O'Connor, Principal Investigator, Mayo Clinic
ClinicalTrials.gov 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes