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

This study has been terminated.
(No correlation between FIAU uptake and bone biopsy results.)
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier:
NCT01764919
First received: January 7, 2013
Last updated: April 6, 2016
Last verified: April 2016
Results First Received: January 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetic Foot Infection
Intervention: Radiation: [124I]FIAU

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
[124I]FIAU

Single intravenous injection of [124I]FIAU in patients with diabetic foot infection

[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.


Participant Flow:   Overall Study
    [124I]FIAU  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
[124I]FIAU

Single intravenous injection of [124I]FIAU in patients with diabetic foot infection

[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.


Baseline Measures
    [124I]FIAU  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     3  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Assess the Safety and Tolerability of [124I]FIAU   [ Time Frame: 30 +/- 2 days ]

3.  Secondary:   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 ]

4.  Secondary:   Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI   [ Time Frame: -2 to 72 hours post dose [124I]FIAU ]

5.  Other Pre-specified:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Michelle Zhang, Executive Director
Organization: Biomed valley discoveries
phone: 7815339412
e-mail: mzhang@biomed-valley.com



Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01764919     History of Changes
Other Study ID Numbers: BVD003
Study First Received: January 7, 2013
Results First Received: January 11, 2016
Last Updated: April 6, 2016
Health Authority: United States: Food and Drug Administration