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OpenTrials
Completed

NCT Number: NCT03229772

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Center

Haifa, 3109601, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

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).

Primary outcomes

  1. Diagnostic Image Quality

    Time frame: 12 weeks

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

  2. Image Resolution

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2017
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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