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

NCT01764919 | Terminated Phase 2 Results

• 1 other identifier: BVD003
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (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.

  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.

  30 hours

Secondary Outcomes (3)

• Assess the Safety and Tolerability of [124I]FIAU

  30 +/- 2 days

• 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

  -2 to 72 hours post dose [124I]FIAU

• Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI

  -2 to 72 hours post dose [124I]FIAU

Other Outcomes (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).

  -2 hours to 72 hours post dose [124I]FIAU

Study Arms (1)

[124I]FIAU

EXPERIMENTAL

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

Radiation: [124I]FIAU

Interventions

[124I]FIAU RADIATION

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

[124I]FIAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients \>/= 18 years on the day of signing consent.
• 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.
• Ability to provide informed consent
• 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.
• For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
• For females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving \[124I\]FIAU.
• Ability to return for all study assessments.
• Clinically euthyroid, or on stable thyroid replacement therapy.

You may not qualify if:

• Patients who ar unable to comply with study requirements.
• 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.
• 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 \[MELAS\])
• Alanine aminotransferase (ALT)\>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) \>5x ULN.
• Body mass that exceeds the rating of the CT table.
• Hypersensitivity to iodine.
• Pregnant or breast-feeding.
• Any condition that would put the patient at unreasonable risk in the opinion of the Investigator.

Sponsors & Collaborators

• BioMed Valley Discoveries, Inc: lead

Study Sites (3)

The University of Arizona

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Dr. Michelle Zhang, Executive Director
• Organization: Biomed valley discoveries

mzhang@biomed-valley.com

7815339412

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 10, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 8, 2016
• Results First Posted: April 8, 2016

Record last verified: 2016-04

Locations

US (3)