Trial Outcomes & Findings for [124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection (NCT NCT01764919)

NCT ID: NCT01764919

Last Updated: 2016-04-08

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 30 hours
• Results posted on: 2016-04-08

Participant Flow

Participant milestones

Measure	[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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	[124I]FIAU n=4 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	[124I]FIAU n=4 Participants 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.
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. Patient positive with both PET-CT and bone biopsy	0 participants
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. Patient negative with both PET-CT and bone biopsy	1 participants
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. Patient positive with PET-CT only	1 participants
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. Patient positive with bone biopsy only	2 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	[124I]FIAU n=4 Participants 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.
Assess the Safety and Tolerability of [124I]FIAU	2 participants with adverse events

SECONDARY outcome

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

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

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

Outcome measures

Outcome data not reported

Adverse Events

[124I]FIAU

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	[124I]FIAU n=4 participants at risk 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.
Injury, poisoning and procedural complications wound dehiscence	25.0% 1/4

Other adverse events

Measure	[124I]FIAU n=4 participants at risk 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.
Investigations mild gamma-glutamyl transferase (GGT) increased	25.0% 1/4
Blood and lymphatic system disorders anemia	25.0% 1/4
Gastrointestinal disorders nausea	25.0% 1/4
Respiratory, thoracic and mediastinal disorders cough	25.0% 1/4
Blood and lymphatic system disorders hypoglycemia	25.0% 1/4
Renal and urinary disorders chronic renal failure	25.0% 1/4
Investigations mild blood alkaline phosphatase increased	25.0% 1/4

Additional Information

Dr. Michelle Zhang, Executive Director

Biomed valley discoveries

Phone: 7815339412

Email: mzhang@biomed-valley.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60