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NCT00416065 Clinical Trial

PET/CT to Identify "Vulnerable" Arterial Plaque

Cancer Clinical Trial

Official title:
PET/CT to Identify "Vulnerable" Arterial Plaque

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00416065
Other study ID # plaqueCTIL
Secondary ID
Status Recruiting
Phase N/A
First received December 26, 2006
Last updated December 26, 2006
Start date April 2004

Study information
Verified date November 2006
Source Rambam Health Care Campus
Contact Ora Israel, MD
Phone 972-4-8543009
Email o_israel@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was increases incalcified plaque or in a different location in the arterial wall. we will also evaluate the relationship between FDG localization and future cardiovascular events in out patient population

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Patients referred for clinical FDG-PET/CT studies

- Patients 50 yr or older

- Patients signed informed consent

Exclusion Criteria:

- Patients unable or unwilling to tolerate the scan until its completion

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• PET/CT 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
Secondary the impact of the imaging modality on patient management
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