[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
  Purpose

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 Intervention Phase
Diabetic Foot Infection
Radiation: [124I]FIAU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by BioMed Valley Discoveries, Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01764919

Locations
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

No publications provided

Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01764919     History of Changes
Other Study ID Numbers: BVD003
Study First Received: January 7, 2013
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteomyelitis
Diabetic Foot
Focal Infection
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Fialuridine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014