Hybrid Imaging Modalities for the Evaluation of Infection
Primary Purpose
Infectious Diseases
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Infectious Diseases
Eligibility 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
Sites / Locations
- Rambam Medical Center
Outcomes
Primary Outcome Measures
The impact of the imaging modality on patient management
Secondary Outcome Measures
The impact of the imaging modality on patient management
Full Information
NCT ID
NCT00230152
First Posted
September 29, 2005
Last Updated
October 21, 2010
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00230152
Brief Title
Hybrid Imaging Modalities for the Evaluation of Infection
Official Title
Nuclear Medicine for the Evaluation of Infection-the Added Value of Hybrid Imaging Modalities
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Imaging
Primary Outcome Measure Information:
Title
The impact of the imaging modality on patient management
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The impact of the imaging modality on patient management
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zohar Keidar, MD, PhD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Hybrid Imaging Modalities for the Evaluation of Infection
We'll reach out to this number within 24 hrs