Rochester, Minnesota 55905

  • Focus of Study is Comparison of 2 Types of Gamma Cameras

Purpose:

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.


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.


Study is Available At:


Original ID:

20-001511


NCT ID:

NCT04722185


Secondary ID:


Study Acronym:


Brief Title:

Evaluation of the Veriton SPECT/CT System


Official Title:

Evaluation of the Veriton SPECT/CT System


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

270


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Michael K O'Connor, PhD
Principal Investigator
Mayo Clinic
Primary Contact:Kera Delaney
507-293-5660
Delaney.Kera@mayo.edu
Backup Contact:Michael K O'Connor, PhD
15073190142
mkoconnor@mayo.edu

Study Dates

Start Date:January 20, 2021
Completion Date:January 2, 2022
Completion Type:Anticipated
Primary Completion Date:January 1, 2022
Primary Completion Type:Anticipated
Verification Date:January 2021
Last Changed Date:January 20, 2021
First Received Date:January 20, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Image quality
Time Frame:1 year
Safety Issues:False
Description:Assessment of relative image quality between the Veriton system and a conventional gamma camera as a function of the type of nuclear medicine exam.

Study Interventions

Intervention Type:Diagnostic Test
Name:Veriton SPECT/CT
Description: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.
Arm Name:Evaluation of the Veriton SPECT/CT system

Study Arms

Study Arm Type:Experimental
Arm Name:Evaluation of the Veriton SPECT/CT system
Description:To determine if the Veriton system can achieve equal or better image quality than a standard SPECT/CT system.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

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