Trial Outcomes & Findings for [124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint (NCT NCT01705496)
NCT ID: NCT01705496
Last Updated: 2016-03-07
Results Overview
The sensitivity and specificity of \[124I\]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee. * Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected \[AC\] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
TERMINATED
PHASE2
23 participants
30 hours
2016-03-07
Participant Flow
Participant milestones
| Measure |
[124I]FIAU
Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
\[124I\]FIAU: This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
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|---|---|
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Overall Study
STARTED
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23
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
Baseline characteristics by cohort
| Measure |
[124I]FIAU
n=23 Participants
Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
\[124I\]FIAU: This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
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|---|---|
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Age, Continuous
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64.1 years
STANDARD_DEVIATION 9.11 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 30 hoursPopulation: Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.
The sensitivity and specificity of \[124I\]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee. * Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected \[AC\] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
Outcome measures
| Measure |
[124I]FIAU
n=22 Participants
Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
\[124I\]FIAU: This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
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|---|---|
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Estimate the Sensitivity and Specificity of [124I]FIAU
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80 percentage of participants
Interval 65.0 to 95.0
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SECONDARY outcome
Timeframe: 30 +/- 2 daysPopulation: 22 received the investigational drug. A single IV injection of 5 mCi \[124I\]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.
Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.
Outcome measures
| Measure |
[124I]FIAU
n=22 Participants
Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
\[124I\]FIAU: This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
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|---|---|
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Evaluate the Safety and Tolerability of [124I]FIAU
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15 participants with adverse events
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SECONDARY outcome
Timeframe: 30 +/- 2 daysThe efficacy of \[124I\]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 +/- 2 daysThe trial failed primary outcome, and this secondary outcome was not analyzed
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 +/- 2 daysAn independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms. The trial failed primary outcome, and this secondary outcome was not analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 minsThe adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared. The trial failed primary outcome, and this secondary outcome was not analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 hoursThe adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which \[124I\]FIAU and X-ray are compared. The trial failed primary outcome, and this secondary outcome was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
[124I]FIAU
Serious adverse events
| Measure |
[124I]FIAU
n=22 participants at risk
Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
\[124I\]FIAU: This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
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|---|---|
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Immune system disorders
Hypersensitivity to a concomitant drug
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4.5%
1/22
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Other adverse events
| Measure |
[124I]FIAU
n=22 participants at risk
Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
\[124I\]FIAU: This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
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|---|---|
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Gastrointestinal disorders
Diarrhoea and nausea
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18.2%
4/22
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Blood and lymphatic system disorders
Leukocytosis & Thrombocytosis
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9.1%
2/22
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General disorders
Injection site pain
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4.5%
1/22
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Infections and infestations
Urinary tract infection
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9.1%
2/22
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Injury, poisoning and procedural complications
procedural complications
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18.2%
4/22
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Investigations
Alanine aminotransferase increased
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4.5%
1/22
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Immune system disorders
Drug hypersensitivity
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4.5%
1/22
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Additional Information
Dr. Michelle Zhang, Executive Director
Biomed valley discoveries
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60