Hybrid Imaging Modalities for the Evaluation of Infection

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT00230152

Collaborator

(none)

300

Enrollment

Location

36.9

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Infectious Diseases	Device: Imaging	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Mar 1, 2009

Outcome Measures

Primary Outcome Measures

The impact of the imaging modality on patient management [3 years]

Secondary Outcome Measures

The impact of the imaging modality on patient management [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Rambam Medical Center	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Zohar Keidar, MD, PhD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00230152

Other Study ID Numbers:

infectionCTIL

First Posted:

Sep 30, 2005

Last Update Posted:

Oct 22, 2010

Last Verified:

Sep 1, 2005

Additional relevant MeSH terms:

Infections

Communicable Diseases

Study Results

No Results Posted as of Oct 22, 2010