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

NCT ID: NCT01764919

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[124I]FIAU

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

Group Type: EXPERIMENTAL

[124I]FIAU

Intervention Type: RADIATION

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

Interventions

[124I]FIAU

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

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMed Valley Discoveries, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Arizona

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

BVD003

Identifier Type: -

Identifier Source: org_study_id