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Comparative Study With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Periprosthetic Joint Infection

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ClinicalTrials.gov Identifier: NCT02855190
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Tzu-Chen Yen, Chang Gung Memorial Hospital

Brief Summary:

This is an open-labelled two-arm pilot comparative prospective study. All the subjects will undergo image assessment in the two stages of exchange arthroplasty surgery. At the first stage, each enrolled subject will receive both FDG and Ga68 citrate PET/CT scans before the first operation for periprosthetic Joint Infection (PJI). Thus, the test results of FDG and Ga68 for each individual can be obtained. After the first operation, the surgery/biopsy proof can be obtained as the gold standard. The subjects those with PJI negative will complete the process at the first stage.

And the second stage of this study will be based on the subjects with positive PJI from the first operation. They will receive both FDG and Ga68 citrate PET/MR scans after antibiotic bone cement was implanted. The sensitivity/accuracy of the two tracers for PET/MR can be calculated and compared. This stage is aimed to answer whether PET/MR scan is a feasible imaging tool to provide diagnostic information of infection control status after the resection arthroplasty of hip/knee PJIs, especially with the implantation of antibiotic loaded bone cement.

In the second stage, the investigators shift the imaging modality to PET/MR based on the following reasons: (1) MRI itself has no radiation burden; (2) MRI provides more accurate tissue contrast information and therefore better anatomic delineation; and (3) currently there was no study indicating the existence of ABLC may hamper the interpretation of images.

The study duration is expected to be completed in a period of 3 year. It plans to enrol a total of 40 evaluable subjects with suspicious. And we expect the PJI prevalence will be around 75%, i.e. the anticipated number of subjects of true PJI is around 30. The sample size and the prevanence is given based on the clinical availability and consideration.


Condition or disease Intervention/treatment Phase
Infection and Inflammatory Reaction Due to Internal Joint Prosthesis Other: 68Ga-citrate and 18F-FDG PET scans Not Applicable

Detailed Description:

The recruited subject subject with periprosthetic joint infection will undergo total four PET scans at two different stages. At first stage, subsequent FDG PET/CT and Ga68 citrate PET/CT scans on different two days will be arranged before infective prosthesis is removed. Eight to twelve weeks after the 1st stage operation, patient will receive two subsequent PET/MR scans using Ga-68 Citrate and FDG on different two days, respectively. The PET images will be visually examined by a nuclear medicine physician and will be reported if any abnormal uptake higher than background by their location and standard uptake value (SUV). The CT/MR images will be reported by a radiologist using standard reading procedures, respectively. The lesions on the PET scan will be correlated to the computed tomography and magnetic resonance images, and the final sensitivity, specificity, and accuracy will be calculated according to the histopathology results or composite clinical and laboratory data.

On the scan day using Ga68-Citrate, baseline electrocardiogram, complete blood count (CBC), and biochemistry profiles including serum alanine transaminase (ALT) and creatinine (Cre) level will be done prior to injection of the radio-pharmaceutical (Ga68-Citrate). Vital signs will be measured before the scan beginning. After completing exam, the electrocardiogram and vital signs will be measure again, and the subject will be released if there is no discomfort. The subject will return to the clinic within 1 week after Ga68-citrate scan. CBC, biochemistry profiles will be checked again for safety monitoring.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Comparative Study of PET/MR and PET/CT With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Periprosthetic Joint Infection
Actual Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: 68Ga-citrate and 18F-FDG PET scans
The recruited subject with surgery/pathology proved periprosthetic joint infection will undergo total four PET scans at two different stages. At first stage, subsequent FDG PET/CT and Ga68 citrate PET/CT scans on different two days will be arranged before infective prosthesis is removed. Eight to twelve weeks after the 1st stage operation, patient will receive two subsequent PET/MR scans using Ga-68 Citrate and FDG on different two days, respectively. For the subject without surgery/pathology proved infection, PET/MR scans will NOT be applied.
Other: 68Ga-citrate and 18F-FDG PET scans
68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations




Primary Outcome Measures :
  1. sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with clinically-proved or -suspicious periprosthetic joint infection and treated with two-stage exchange arthroplasty
  2. Age equals or more than 20 years old
  3. Willing to sign the informed consent

Exclusion Criteria:

  1. Unable to tolerate PET/MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), claustrophobia, unable to lie still, allergy to medium contrast.
  2. Unable to give informed consent
  3. Patient who is pregnant or lactating
  4. Unwilling to use contraceptives during nuclide medicine examinations.
  5. Allergy history to FDG or Ga68-citrate, significant abnormal lab data, and high risk to conduct examination after evaluations of PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855190


Contacts
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Contact: Yen Tzu-Chen, MD,PhD 03-328-1200 ext 2744 yen1110@adm.cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital at Linkou Recruiting
Taoyuan, Taiwan, 333
Contact: Jing-Ren Tseng, MD    +886- 3281200 ext 2744    drtsengjr@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Yen Tzu-Chen, MD,PhD Chang Gung Memorial Hospital

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tzu-Chen Yen, Principal Investigator, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02855190     History of Changes
Other Study ID Numbers: 103-7226A
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Tzu-Chen Yen, Chang Gung Memorial Hospital:
Ga68-citrate
FDG
PET/MR and PET/CT
Periprosthetic joint infection

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Inflammation
Pathologic Processes
Citric Acid
Sodium Citrate
Fluorodeoxyglucose F18
Gallium citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals