Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2017-03-06
2020-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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68Gallium-citrate
This arm, undergoing the "68-Gallium citrate PET/CT scan intervention", includes the PET/CT scans performed with 68Gallium-citrate radiotracer. Note that same patients scanned with different radiotracers serve in both arms.
68-Gallium citrate PET/CT scan
After establishment of an intravenous access, approximately 5 mCi of 68Ga-citrate (Zevacor Molecular, Somerset, NJ, USA) will be administered intravenously. Whole body PET/CT scan will be performed after 60 minutes of uptake phase.
18F-FDG
This arm, undergoing the "18F FDG PET/CT scan intervention", includes the PET/CT scans performed with 18F-FDG tracer.
Note that same patients scanned with different radiotracers serve in both arms.
18F FDG PET/CT scan
Subjects will undergo FDG PET/CT scan using the same imaging parameters either on the same day or within the next 24-48 hours. The subjects will be requested to fast for a minimum of 4 h prior to PET acquisition. After confirmation of a blood glucose level ≤200 mg/dl, technologists will establish the intravenous access and the subject will receive approximately 10 mCi of 18F-FDG (Zevacor Molecular, Somerset, NJ, USA) intravenously. The subject will be placed in uptake room for 60 minutes to allow for optimal localization of the compound. The subjects will be requested to void prior to administration of 18FDG and again prior to image acquisition.
Interventions
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68-Gallium citrate PET/CT scan
After establishment of an intravenous access, approximately 5 mCi of 68Ga-citrate (Zevacor Molecular, Somerset, NJ, USA) will be administered intravenously. Whole body PET/CT scan will be performed after 60 minutes of uptake phase.
18F FDG PET/CT scan
Subjects will undergo FDG PET/CT scan using the same imaging parameters either on the same day or within the next 24-48 hours. The subjects will be requested to fast for a minimum of 4 h prior to PET acquisition. After confirmation of a blood glucose level ≤200 mg/dl, technologists will establish the intravenous access and the subject will receive approximately 10 mCi of 18F-FDG (Zevacor Molecular, Somerset, NJ, USA) intravenously. The subject will be placed in uptake room for 60 minutes to allow for optimal localization of the compound. The subjects will be requested to void prior to administration of 18FDG and again prior to image acquisition.
Eligibility Criteria
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Inclusion Criteria
* Radiographic studies compatible with prosthesis loosening (i.e. periprosthetic infection or aseptic loosening).
* Pending surgical evaluation and tissue sampling within the next few weeks to differentiate between infection and aseptic loosening.
Exclusion Criteria
* Pregnancy or known or suspected hypersensitivity to metals or gallium
* Joint replacement for any reason other than primary or secondary osteoarthritis
* Prior surgical therapy for prosthesis failure after initial hospital discharge
* Active inflammatory/infectious process at any location other than prosthetic joint (Sarcoidosis, Rheumatoid arthritis, HIV infection, SLE)
18 Years
ALL
No
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Nasrin Ghesani
Associate Professor
Principal Investigators
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Nasrin Ghesani, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Locations
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Rutgers New Jersey Medical School
Newark, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20160000134
Identifier Type: -
Identifier Source: org_study_id
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