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Hybrid Imaging Modalities for the Evaluation of Infection

Primary Purpose

Infectious Diseases

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Imaging

About this trial

This is an interventional diagnostic trial for Infectious Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

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

Eligibility Criteria

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

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