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

General Electric (GE)

Status: Completed

Conditions: Cancer

Treatments: Device: Discovery NM/CT 670 CZT Imaging Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03229772

117.02-2015-GES-0002

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Subjects indicated for dynamic nuclear medicine scanning

Other group

Description:

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.

Treatment:

Device: Discovery NM/CT 670 CZT Imaging Scan