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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229772
• Other study ID #: 117.02-2015-GES-0002
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: July 24, 2017
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2017
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Discovery NM/CT 670 CZT Imaging Scan
At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).

Locations

Country	Name	City	State
Israel	Rambam Health Care Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Image Quality	Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale	12 weeks
Primary	Image Resolution	Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale	12 weeks