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F18-Flouride PET/CT in Acute Knee Injury

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ClinicalTrials.gov Identifier: NCT00687921
Recruitment Status : Unknown
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2008
Last Update Posted : June 2, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

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 or disease
Knee Injury

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


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: F18-Flouride PET/CT in Acute Knee Injury. A Prospective Study
Study Start Date : June 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   None Retained
not relevant


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Einat Even-Sapir MD, PhD, Dept of Nuclear Medicine. Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00687921     History of Changes
Other Study ID Numbers: TASMC-08-EE-118-CTIL
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: June 2, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Wounds and Injuries
Knee Injuries
Leg Injuries