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PI left the institute and the funding expired.
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In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients with failed joint prosthesis and compare it with that of conventional 18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within 24-48 hours from each other, will be performed within 4 weeks before surgical evaluation/revision of the hardware.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Gallium-citrate | Experimental | 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. |
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| 18F-FDG | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68-Gallium citrate PET/CT scan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis | The radiotracer uptake in SUV units is measured in different Gruen zones around the prosthesis and normalized by that of the liver. The values of the two scans will be compared against each other for all patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, and accuracy of 68Gallium-citrate and 18F-FDG scans, by using surgical pathology results as the gold standard. | Using the surgical histology and tissue culture as the gold standard, sensitivity and specificity of both techniques will be calculated. The aim is determine which modality has more accuracy to differentiate septic prosthesis failure from aseptic entities. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nasrin Ghesani, MD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2018 | Nov 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2018 | Apr 12, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2018 | Nov 19, 2020 | ICF_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2021 | Oct 13, 2021 | 8 | ||
| Nov 7, 2021 |
Same patients are scanned with two radiotracers within 24-48 hours. Results of the two scans are compared against each other.
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| 18F FDG PET/CT scan | Drug | 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. |
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| Dec 6, 2021 |
| 9 |