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This study has been withdrawn prior to enrollment.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:
Information provided by:
Spectrum Dynamics
ClinicalTrials.gov Identifier:
NCT00979355
First received: September 17, 2009
Last updated: June 24, 2010
Last verified: June 2010
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT00979355     History of Changes
Other Study ID Numbers: GP- DSpect_001
Study First Received: September 17, 2009
Last Updated: June 24, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Spectrum Dynamics:
Whole body
SPECT

ClinicalTrials.gov processed this record on August 26, 2014