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

NCT ID: NCT03229772

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects indicated for dynamic nuclear medicine scanning

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.

Group Type: OTHER

Discovery NM/CT 670 CZT Imaging Scan

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zohar Keidar, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Center

Locations

Rambam Health Care Center

Haifa, , Israel

Countries

Israel

Other Identifiers

117.02-2015-GES-0002

Identifier Type: -

Identifier Source: org_study_id