Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Device: Discovery NM/CT 670 CZT Imaging Scan

• Registration Number: NCT03229772
• Lead Sponsor: GE Healthcare

Brief Summary

The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Study First Submitted: 2016-05-11
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-24
• Last Update Submitted: 2017-07-24
• Study First Posted: 2017-07-26
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. are 18-years old and older;
2. is able to sign and date the informed consent form; AND
3. have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device.

Exclusion Criteria

1. Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient.
2. Pregnant or lactating women
3. Who were previously enrolled in this study;
4. Who have contraindication for the radiopharmaceutical
5. Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects indicated for dynamic nuclear medicine scanning	Discovery NM/CT 670 CZT Imaging Scan	The trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit.

Primary Outcome Measures

Name	Time	Method
Image Resolution	12 weeks	Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale
Diagnostic Image Quality	12 weeks	Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale

Trial Locations

Locations (1)

Rambam Health Care Center; 🇮🇱 Haifa, Israel