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Trial record 23 of 47 for:    "Prosthetic Joint Infection"

[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint (PJI)

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ClinicalTrials.gov Identifier: NCT01705496
Recruitment Status : Terminated (The sensitivity and specificity were not able to be assessed in this study due to the poor image quality.)
First Posted : October 12, 2012
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prosthetic Joint Infections
Intervention Radiation: [124I]FIAU
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title [124I]FIAU
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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.

Period Title: Overall Study
Started 23
Completed 19
Not Completed 4
Arm/Group Title [124I]FIAU
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
64.1  (9.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
7
  30.4%
Male
16
  69.6%
1.Primary Outcome
Title Estimate the Sensitivity and Specificity of [124I]FIAU
Hide Description

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.
Time Frame 30 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
80
(65 to 95)
2.Secondary Outcome
Title Evaluate the Safety and Tolerability of [124I]FIAU
Hide Description 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.
Time Frame 30 +/- 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants with adverse events
15
3.Secondary Outcome
Title Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints
Hide Description The 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.
Time Frame 30 +/- 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Understand the Prevalence of Prosthetic Joint Infection
Hide Description The trial failed primary outcome, and this secondary outcome was not analyzed
Time Frame 30 +/- 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards
Hide Description

An 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.

Time Frame 30 +/- 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection
Hide Description

The 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.

Time Frame 15 mins
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection
Hide Description

The 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.

Time Frame 30 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [124I]FIAU
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title [124I]FIAU
Hide Arm/Group Description

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.

All-Cause Mortality
[124I]FIAU
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
[124I]FIAU
Affected / at Risk (%)
Total   1/22 (4.55%) 
Immune system disorders   
Hypersensitivity to a concomitant drug  1/22 (4.55%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[124I]FIAU
Affected / at Risk (%)
Total   15/22 (68.18%) 
Blood and lymphatic system disorders   
Leukocytosis & Thrombocytosis  2/22 (9.09%) 
Gastrointestinal disorders   
Diarrhoea and nausea  4/22 (18.18%) 
General disorders   
Injection site pain  1/22 (4.55%) 
Immune system disorders   
Drug hypersensitivity  1/22 (4.55%) 
Infections and infestations   
Urinary tract infection  2/22 (9.09%) 
Injury, poisoning and procedural complications   
procedural complications  4/22 (18.18%) 
Investigations   
Alanine aminotransferase increased  1/22 (4.55%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michelle Zhang, Executive Director
Organization: Biomed valley discoveries
Phone: 7815339412
Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01705496     History of Changes
Other Study ID Numbers: BVD002
First Submitted: October 10, 2012
First Posted: October 12, 2012
Results First Submitted: January 11, 2016
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016