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[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection

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ClinicalTrials.gov Identifier: NCT01764919
Recruitment Status : Terminated (No correlation between FIAU uptake and bone biopsy results.)
First Posted : January 10, 2013
Results First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Study Description
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Brief Summary:
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.

Condition or disease Intervention/treatment Phase
Diabetic Foot Infection Radiation: [124I]FIAU Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: [124I]FIAU
Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
 Radiation: [124I]FIAU
A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.


Outcome Measures
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Primary Outcome Measures :
  1. Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection. [ Time Frame: 30 hours ]
    A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.


Secondary Outcome Measures :
  1. Assess the Safety and Tolerability of [124I]FIAU [ Time Frame: 30 +/- 2 days ]
    Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.

  2. Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection [ Time Frame: -2 to 72 hours post dose [124I]FIAU ]
    All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.

  3. Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI [ Time Frame: -2 to 72 hours post dose [124I]FIAU ]
    Additional information on the extent and localization of infection will be compared to MRI.


Other Outcome Measures:
  1. Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5). [ Time Frame: -2 hours to 72 hours post dose [124I]FIAU ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients >/= 18 years on the day of signing consent.
  2. A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or receipt of antidiabetic medication at time of enrollment.
  3. Ability to provide informed consent
  4. An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with PEDIS grade 4 infections may be included if they are sufficiently stable.
  5. For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
  6. For females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving [124I]FIAU.
  7. Ability to return for all study assessments.
  8. Clinically euthyroid, or on stable thyroid replacement therapy.

Exclusion Criteria:

  1. Patients who ar unable to comply with study requirements.
  2. Indication, in the opinion of the principal Investigator for urgent surgery that would preclude the time needed for PET-CT scanning, or clinical instability that precludes PET-CT scanning.
  3. History of an inherited mitochondrial disorder (eg. Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myocolonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
  4. Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) >5x ULN.
  5. Body mass that exceeds the rating of the CT table.
  6. Hypersensitivity to iodine.
  7. Pregnant or breast-feeding.
  8. Any condition that would put the patient at unreasonable risk in the opinion of the Investigator.
Contacts and Locations
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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): NCT01764919


Locations
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United States, Arizona
The University of Arizona
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
BioMed Valley Discoveries, Inc
More Information
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Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01764919    
Other Study ID Numbers: BVD003
First Posted: January 10, 2013    Key Record Dates
Results First Posted: April 8, 2016
Last Update Posted: April 8, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Osteomyelitis
Focal Infection
Diabetic Foot
Disease Attributes
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
 Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases