Clinical Trial: FDG-PET Imaging in Complicated Diabetic Foot
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: FDG-PET Imaging in Complicated Diabetic Foot (Protocol Version Dated 3/01/2004)
Brief Summary: The main objective of the proposed research study is to determine the potential utilization of [18-F] Fluorodeoxyglucose (FDG) positron emission tomography (PET) in patients with complicated diabetic foot, especially in the diagnosis or exclusion of osteomyelitis in this setting. We intend to validate and establish the necessary criteria for making such a diagnosis and determine the accuracy of the technique through comparison with other existing modalities, including MRI, and patient outcome. We expect that at the completion of the proposed research, the role of these powerful imaging modalities will be clearly defined in the management of patients with this challenging and serious complication.
Detailed Summary:
FDG-PET imaging is a promising imaging technique, which has the potential to overcome many of the shortcomings mentioned previously with regard to radiologic and scintigraphic methodologies. FDG is a diagnostic tracer utilized to measure the metabolic rates of normal and abnormal tissues. Many investigators have noted the affinity of FDG for active inflammatory and infectious disorders, such as sarcoidosis, the abdominal abscess, brain abscess, lung abscess, renal abscess, inflammatory pancreatic disease, lobar pneumonia, asthma, tuberculosis, colitis, sinusitis, myositis, mastitis, vasculitis, deep venous thrombosis, thyroiditis and other infections including those encountered in orthopedic patients.
According to the literature, the most accurate nuclear medicine modality for detecting infection associated with diabetic foot is the labeled WBC method. We hypothesize that FDG-PET imaging has several advantages over this method. Detection of infection by labeled WBC imaging is based upon the assumption that the administered cells will migrate to the sites of infection. Since the majority of the labeled leukocyte preparation consists of neutrophils, inflammatory/infectious processes with a predominantly neutrophilic infiltrate (acute infections) are likely to yield positive results. However, most infections associated with diabetic foot are sub-acute or chronic. Consequently, the dominant inflammatory cells involved are monocytes and lymphocytes. Therefore, labeled leukocytes are unlikely to detect chronic infection since very few monocytes and lymphocytes are labeled. In addition, the previous treatment (antibiotics, etc) can severely reduce the chemotropic effect of bacteria and therefore, fewer leukocytes will migrate to the infectious sites, rendering the labeled leukocyte method ineffective.
In contrast, the uptake of F
Sponsor: University of Pennsylvania
Current Primary Outcome: SUV measurement from PET scan [ Time Frame: Following completion of PET scan ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Pennsylvania
Dates:
Date Received: September 13, 2005
Date Started: October 2002
Date Completion: January 2020
Last Updated: April 28, 2017
Last Verified: April 2017
