Hybrid Imaging Modalities for the Evaluation of Infection

Infectious Diseases Clinical Trial

Official title:

Nuclear Medicine for the Evaluation of Infection-the Added Value of Hybrid Imaging Modalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230152
• Other study ID #: infectionCTIL
• Status: Completed
• Phase: N/A
• First received: September 29, 2005
• Last updated: October 21, 2010
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2005
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2009
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Intervention

Device:
• Imaging

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of the imaging modality on patient management		3 years	No
Secondary	The impact of the imaging modality on patient management		2 years	No