NCT00230152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 22, 2010

Status Verified

September 1, 2005

Enrollment Period

1.2 years

First QC Date

September 29, 2005

Last Update Submit

October 21, 2010

Conditions

Infectious Diseases

Outcome Measures

Primary Outcomes (1)

  • The impact of the imaging modality on patient management

    3 years

Secondary Outcomes (1)

  • The impact of the imaging modality on patient management

    2 years

Interventions

ImagingDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Zohar Keidar, MD, PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2005

First Posted

September 30, 2005

Study Start

February 1, 2006

Primary Completion

April 1, 2007

Study Completion

March 1, 2009

Last Updated

October 22, 2010

Record last verified: 2005-09

Locations

IL(1)