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F18-Flouride PET/CT in Acute Knee Injury

This study is not yet open for participant recruitment.
Verified by Tel-Aviv Sourasky Medical Center, May 2008

Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00687921
  Purpose

18F-fluoride is a positron-emitting bone-seeking agent with favorable pharmacokinetic properties. Its uptake mechanism resembles that of 99mTc-MDP. After IV administration, 18F-fluoride diffuses through the bone capillaries into the bone extracellular fluid (ECF). Its plasma clearance is more rapid than that of 99mTc-MDP and its single-passage extraction efficiency is higher. The fast blood clearance of 18F-fluoride results in a better target- to- background ratio. Bone uptake of 18F-fluoride is two-fold higher than that of 99mTc-MDP. Combining the favorable pharmacokinetic characteristics of 18F-fluoride with the high performance of PET technology, 18F-fluoride is a valuable imaging modality of the skeleton.

There are only few manuscripts on the role of static 18F-fluoride PET for detection of lesions in patients referred for non-oncologic indications The purpose of the study is to prospectively assess the added value of Fluoride PET/CT in the clinical setting of acute knee injury. The findings of Fluoride PET/CT will be correlated with those found on arthroscopy and MRI which the currently used diagnostic techniques with a high, however, not perfect diagnostic accuracy regarding the issue of bone injury which is a critical component on the long term outcome after knee injury.


Condition
Knee Injury

MedlinePlus related topics:   Injuries    Knee Injuries and Disorders    Wounds   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   F18-Flouride PET/CT in Acute Knee Injury. A Prospective Study

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • we will refer patients over the age of 18 who had knee trauma, intent to or had MRI assessment and are scheduled for arthroscopy. The compartments of the injured knee will be evaluated on each of the modalities. [ Time Frame: 6 mounth ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

not relevant


Estimated Enrollment:   50
Study Start Date:   June 2008
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
A
patients over the age of 18 who had knee trauma, intent to or had MRI assessment and are scheduled for arthroscopy.

Detailed Description:

We intend to inject only 5mCi of Fluoride, as we already did before, thus reducing the radiation exposure to half of that of the routine Tc-MDP bone scintigraphy.

We will refer 50 patients over the age of 18 who had knee trauma, intent to or had MRI assessment and are scheduled for arthroscopy. The compartments of the injured knee will be evaluated on each of the modalities.

Exclusion criterion is pregnancy

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

patients over the age of 18 who had knee trauma, intent to or had MRI assessment and are scheduled for arthroscopy


Criteria

Inclusion Criteria:

  • patients over the age of 18 who had knee trauma

Exclusion Criteria:

  • pregnancy
  • age under 18 years
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687921

Contacts
Contact: Einat Even-sapir, PhD, MD     972-3-697-3432     evensap@tasmc.health.gov.il    

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Investigators
Principal Investigator:     Einat R. Even-Sapir, MD, PhD     Tel-Aviv Sourasky Medical Center    
  More Information

Responsible Party:   Dept of Nuclear Medicine. Tel Aviv Sourasky Medical Center ( Einat Even-Sapir MD, PhD )
Study ID Numbers:   TASMC-08-EE-118-CTIL
First Received:   May 28, 2008
Last Updated:   May 30, 2008
ClinicalTrials.gov Identifier:   NCT00687921
Health Authority:   Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Knee trauma  
MRI  
arthroscopy  
Patients over the age of 18 who had knee trauma intent to or had MRI assessment scheduled for arthroscopy  

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 05, 2008




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