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Study to Compare a Fast Gama Camera for Nuclear Imaging to Conventional Camera (GP_D-Spect)

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ClinicalTrials.gov Identifier: NCT00979355
Recruitment Status : Withdrawn
First Posted : September 18, 2009
Last Update Posted : June 28, 2010
Sponsor:
Information provided by:
Spectrum Dynamics

Brief Summary:
A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.

Condition or disease Intervention/treatment Phase
Detect Pathalogical Lesions Device: GP-D-SPECT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans
Study Start Date : November 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Intervention Details:
    Device: GP-D-SPECT
    The D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large PMTs. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient.


Primary Outcome Measures :
  1. A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions. [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to image quality/resolution [ Time Frame: 12 month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is referred to nuclear medicine department for a SPECT scan.
  2. Written informed consent is obtained by a study investigator.

Exclusion Criteria:

  1. Patient pregnancy (known or suspected).
  2. Lack of written informed consent
  3. Prisoner status
  4. Patient under age 18 or over 80 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979355


Locations
Israel
Bnai Zion Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Spectrum Dynamics
Investigators
Principal Investigator: MIGUEL GORENBERG, MD Bnai Zion Medical Center

Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT00979355     History of Changes
Other Study ID Numbers: GP- DSpect_001
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010

Keywords provided by Spectrum Dynamics:
Whole body
SPECT