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Hybrid Imaging Modalities for the Evaluation of Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230152
First Posted: September 30, 2005
Last Update Posted: October 22, 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:
Rambam Health Care Campus
  Purpose

The synergistic value of the fusion of physiologic and anatomical data has been described using several co-registration techniques for various nuclear medicine procedures and morphologic imaging modalities (single photon emission computed tomography-computed tomography [SPECT-CT], SPECT-magnetic resonance imaging [MRI], camera-based positron emission tomography [PET]-CT and PET-CT). The researchers hypothesize that fusion of nuclear medicine (NM) and CT data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. They hypothesize that more accurate localization of increased radiotracer activity on NM procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management.

The purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.


Condition Intervention
Infectious Diseases Device: Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Nuclear Medicine for the Evaluation of Infection-the Added Value of Hybrid Imaging Modalities

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • The impact of the imaging modality on patient management [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • The impact of the imaging modality on patient management [ Time Frame: 2 years ]

Enrollment: 300
Study Start Date: February 2006
Study Completion Date: March 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The researchers hypothesize that fusion of nuclear medicine (NM) and CT data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. They hypothesize that more accurate localization of increased radiotracer activity on NM procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management.

The purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients referred for NM imaging procedures to assess the presence of infectious processes.
  • Patients signed informed consent

Exclusion Criteria:

  • The study will not be performed in pregnant or lactating women.
  • Patients unable or unwilling to tolerate the scan until its completion
  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): NCT00230152


Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Zohar Keidar, MD, PhD Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00230152     History of Changes
Other Study ID Numbers: infectionCTIL
First Submitted: September 29, 2005
First Posted: September 30, 2005
Last Update Posted: October 22, 2010
Last Verified: September 2005

Additional relevant MeSH terms:
Communicable Diseases
Infection