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

NCT03229772 | Completed

• 1 other identifier: 117.02-2015-GES-0002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Diagnostic Image Quality

  Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale

  12 weeks

• Image Resolution

  Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale

  12 weeks

Study Arms (1)

Subjects indicated for dynamic nuclear medicine scanning

OTHER

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.

Device: Discovery NM/CT 670 CZT Imaging Scan

Interventions

Discovery NM/CT 670 CZT Imaging Scan 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).

Subjects indicated for dynamic nuclear medicine scanning

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnant or lactating women
• Who were previously enrolled in this study;
• Who have contraindication for the radiopharmaceutical
• 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;

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Rambam Health Care Center

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zohar Keidar, MD

  Rambam Health Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: July 26, 2017
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)