Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194298
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2005-09-13
Brief Title:
FDG-PET Imaging in Complicated Diabetic Foot
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
FDG-PET Imaging in Complicated Diabetic Foot Protocol Version Dated 3012004
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 inflammatoryinfectious 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 FDG in inflammatory cells reflects in vivo labeling of the existing cells at the site of infection soon after the administration of the compound This would indicate that FDG-PET technique might allow imaging a substantially larger population of cells which are residing in the area of infection and inflammation Therefore in addition to considerable simplification of procedures associated with the labeled WBC method including the time required to complete the study this approach may provide higher sensitivity for diagnosing infection in such settings Furthermore since FDG uptake does not rely upon leukocyte migration treatment with antibiotics is less likely to affect its sensitivity in delineating the sites of infection One possible advantage of the labeled WBC method over FDG-PET imaging is that high serum glucose levels do not appear to have an adverse effect on the test results with the former technique while hyperglycemia is known to decrease tumor cell FDG uptake However our preliminary results indicate that high glucose levels do not negatively affect FDG uptake by inflammatory cells Based on these observations FDG-PET imaging appears to be an attractive alternative to conventional techniques for the detection of infection
FDG-PET imaging offers a unique tool for the diagnosis and management of the diabetic foot Through the establishment of appropriate diagnostic criteria a PET scan may prove to be highly accurate in localizing deep infections of bone and soft tissue associated with the complicated diabetic foot By distinguishing these infections from inflammation it has the potential to become the optimal diagnostic imaging technique with which to diagnose and manage patients with diabetic foot Therefore research studies designed to further validate the ability of this technique are essential to achieving this goal
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 inflammatoryinfectious 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 FDG in inflammatory cells reflects in vivo labeling of the existing cells at the site of infection soon after the administration of the compound This would indicate that FDG-PET technique might allow imaging a substantially larger population of cells which are residing in the area of infection and inflammation Therefore in addition to considerable simplification of procedures associated with the labeled WBC method including the time required to complete the study this approach may provide higher sensitivity for diagnosing infection in such settings Furthermore since FDG uptake does not rely upon leukocyte migration treatment with antibiotics is less likely to affect its sensitivity in delineating the sites of infection One possible advantage of the labeled WBC method over FDG-PET imaging is that high serum glucose levels do not appear to have an adverse effect on the test results with the former technique while hyperglycemia is known to decrease tumor cell FDG uptake However our preliminary results indicate that high glucose levels do not negatively affect FDG uptake by inflammatory cells Based on these observations FDG-PET imaging appears to be an attractive alternative to conventional techniques for the detection of infection
FDG-PET imaging offers a unique tool for the diagnosis and management of the diabetic foot Through the establishment of appropriate diagnostic criteria a PET scan may prove to be highly accurate in localizing deep infections of bone and soft tissue associated with the complicated diabetic foot By distinguishing these infections from inflammation it has the potential to become the optimal diagnostic imaging technique with which to diagnose and manage patients with diabetic foot Therefore research studies designed to further validate the ability of this technique are essential to achieving this goal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None