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F18-Flouride PET/CT in Acute Knee Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00687921
First received: May 28, 2008
Last updated: May 30, 2008
Last verified: May 2008
  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

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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: May 28, 2008
Last Updated: May 30, 2008
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

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

ClinicalTrials.gov processed this record on September 18, 2014