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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier:
NCT01764919
First received: January 7, 2013
Last updated: August 20, 2013
Last verified: August 2013

January 7, 2013
August 20, 2013
January 2013
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Subjects will be dosed with [124I]FIAU. PET-CT scanning will be performed at two time points after dosing.
Same as current
Complete list of historical versions of study NCT01764919 on ClinicalTrials.gov Archive Site
  • Assess the safety and tolerability of [124I]FIAU [ Time Frame: 30 +/- 2 days ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Assess any additional information that [124I]FIAU PET-CT scanning provides compared to MRI [ Time Frame: -2 to 72 hours post dose [124I]FIAU ] [ Designated as safety issue: No ]
    Additional information on the extent and localization of infection will be compared to MRI.
Same as current
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 ] [ Designated as safety issue: No ]
Same as current
 
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.
Experimental: [124I]FIAU
Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
Intervention: Radiation: [124I]FIAU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01764919
BVD003
No
BioMed Valley Discoveries, Inc
BioMed Valley Discoveries, Inc
Not Provided
Not Provided
BioMed Valley Discoveries, Inc
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP