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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979355
First Posted: September 18, 2009
Last Update Posted: June 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Spectrum Dynamics
  Purpose
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 Intervention
Detect Pathalogical Lesions Device: GP-D-SPECT

Study Type: Interventional
Study Design: 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

Further study details as provided by Spectrum Dynamics:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT00979355     History of Changes
Other Study ID Numbers: GP- DSpect_001
First Submitted: September 17, 2009
First Posted: September 18, 2009
Last Update Posted: June 28, 2010
Last Verified: June 2010

Keywords provided by Spectrum Dynamics:
Whole body
SPECT