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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2009

Last Updated Date

June 24, 2010

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00979355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Compare a Fast Gama Camera for Nuclear Imaging to Conventional Camera

Official Title ^ICMJE

Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Detect Pathalogical Lesions

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00979355

Other Study ID Numbers ^ICMJE

GP- DSpect_001

Has Data Monitoring Committee

Not Provided

Responsible Party

Spectrum Dynamics

Study Sponsor ^ICMJE

Spectrum Dynamics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

MIGUEL GORENBERG, MD

Bnai Zion Medical Center

Information Provided By

Spectrum Dynamics

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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