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

• Sponsor: BioMed Valley Discoveries, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01764919
• Collaborator: (none)
• Enrollment: 4
• Locations: 3
• Arm: 1
• Duration (Months): 10.1
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Infection	Radiation: [124I]FIAU	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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. [30 hours]

   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.

Secondary Outcome Measures

1. Assess the Safety and Tolerability of [124I]FIAU [30 +/- 2 days]

   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.

2. 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]

   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.

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

   Additional information on the extent and localization of infection will be compared to MRI.

Other Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The University of Arizona	Tucson	Arizona	United States	85724
2	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• BioMed Valley Discoveries, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioMed Valley Discoveries, Inc
• ClinicalTrials.gov Identifier: NCT01764919
• Other Study ID Numbers: BVD003
• First Posted: Jan 10, 2013
• Last Update Posted: Apr 8, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Infections; Communicable Diseases; Osteomyelitis; Focal Infection; Diabetic Foot

Study Results

Participant Flow

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 25%
Male	3 75%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	30 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Measure Participants	4
Patient positive with both PET-CT and bone biopsy	0 0%
Patient negative with both PET-CT and bone biopsy	1 25%
Patient positive with PET-CT only	1 25%
Patient positive with bone biopsy only	2 50%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Measure Participants	4
Number [participants with adverse events]	2 50%

3. Secondary Outcome

Title	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
Description	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.
Time Frame	-2 to 72 hours post dose [124I]FIAU

Outcome Measure Data

Analysis Population Description

No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Measure Participants	0

4. Secondary Outcome

Title	Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
Description	Additional information on the extent and localization of infection will be compared to MRI.
Time Frame	-2 to 72 hours post dose [124I]FIAU

Outcome Measure Data

Analysis Population Description

No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Measure Participants	0

5. Other Pre-specified Outcome

Title	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

Outcome Measure Data

Analysis Population Description

No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Arm/Group Title	[124I]FIAU
Arm/Group Description	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.
All Cause Mortality
	[124I]FIAU
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	[124I]FIAU
	Affected / at Risk (%)	# Events
Total	1/4 (25%)
Injury, poisoning and procedural complications
wound dehiscence	1/4 (25%)
Other (Not Including Serious) Adverse Events
	[124I]FIAU
	Affected / at Risk (%)	# Events
Total	2/4 (50%)
Blood and lymphatic system disorders
anemia	1/4 (25%)
hypoglycemia	1/4 (25%)
Gastrointestinal disorders
nausea	1/4 (25%)
Investigations
mild gamma-glutamyl transferase (GGT) increased	1/4 (25%)
mild blood alkaline phosphatase increased	1/4 (25%)
Renal and urinary disorders
chronic renal failure	1/4 (25%)
Respiratory, thoracic and mediastinal disorders
cough	1/4 (25%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.