Comparative Study With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Periprosthetic Joint Infection
NCT ID: NCT02855190
Last Updated: 2018-06-21
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-01-31
2018-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
68Ga-citrate and 18F-FDG PET scans
68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations
Interventions
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68Ga-citrate and 18F-FDG PET scans
68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations
Eligibility Criteria
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Inclusion Criteria
2. Age equals or more than 20 years old
3. Willing to sign the informed consent
Exclusion Criteria
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.
20 Years
99 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Tzu-Chen Yen
Principal Investigator
Principal Investigators
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Yen Tzu-Chen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital at Linkou
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Bauman G, Belhocine T, Kovacs M, Ward A, Beheshti M, Rachinsky I. 18F-fluorocholine for prostate cancer imaging: a systematic review of the literature. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):45-55. doi: 10.1038/pcan.2011.35. Epub 2011 Aug 16.
Mohler JL, Armstrong AJ, Bahnson RR, Boston B, Busby JE, D'Amico AV, Eastham JA, Enke CA, Farrington T, Higano CS, Horwitz EM, Kantoff PW, Kawachi MH, Kuettel M, Lee RJ, MacVicar GR, Malcolm AW, Miller D, Plimack ER, Pow-Sang JM, Roach M 3rd, Rohren E, Rosenfeld S, Srinivas S, Strope SA, Tward J, Twardowski P, Walsh PC, Ho M, Shead DA. Prostate cancer, Version 3.2012: featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2012 Sep;10(9):1081-7. doi: 10.6004/jnccn.2012.0114.
Picchio M, Castellucci P. Clinical Indications of C-Choline PET/CT in Prostate Cancer Patients with Biochemical Relapse. Theranostics. 2012;2(3):313-7. doi: 10.7150/thno.4007. Epub 2012 Mar 12.
Schwarzenbock S, Souvatzoglou M, Krause BJ. Choline PET and PET/CT in Primary Diagnosis and Staging of Prostate Cancer. Theranostics. 2012;2(3):318-30. doi: 10.7150/thno.4008. Epub 2012 Mar 15.
Beer AJ, Eiber M, Souvatzoglou M, Schwaiger M, Krause BJ. Radionuclide and hybrid imaging of recurrent prostate cancer. Lancet Oncol. 2011 Feb;12(2):181-91. doi: 10.1016/S1470-2045(10)70103-0. Epub 2010 Jul 6.
Umbehr MH, Muntener M, Hany T, Sulser T, Bachmann LM. The role of 11C-choline and 18F-fluorocholine positron emission tomography (PET) and PET/CT in prostate cancer: a systematic review and meta-analysis. Eur Urol. 2013 Jul;64(1):106-17. doi: 10.1016/j.eururo.2013.04.019. Epub 2013 Apr 19.
Wetter A, Lipponer C, Nensa F, Beiderwellen K, Olbricht T, Rubben H, Bockisch A, Schlosser T, Heusner TA, Lauenstein TC. Simultaneous 18F choline positron emission tomography/magnetic resonance imaging of the prostate: initial results. Invest Radiol. 2013 May;48(5):256-62. doi: 10.1097/RLI.0b013e318282c654.
Abuzallouf S, Dayes I, Lukka H. Baseline staging of newly diagnosed prostate cancer: a summary of the literature. J Urol. 2004 Jun;171(6 Pt 1):2122-7. doi: 10.1097/01.ju.0000123981.03084.06.
Souvatzoglou M, Eiber M, Martinez-Moeller A, Furst S, Holzapfel K, Maurer T, Ziegler S, Nekolla S, Schwaiger M, Beer AJ. PET/MR in prostate cancer: technical aspects and potential diagnostic value. Eur J Nucl Med Mol Imaging. 2013 Jul;40 Suppl 1:S79-88. doi: 10.1007/s00259-013-2445-4. Epub 2013 May 24.
Tseng JR, Chang YH, Yang LY, Wu CT, Chen SY, Wan CH, Hsiao IT, Yen TC. Potential usefulness of 68Ga-citrate PET/CT in detecting infected lower limb prostheses. EJNMMI Res. 2019 Jan 3;9(1):2. doi: 10.1186/s13550-018-0468-3.
Other Identifiers
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103-7226A
Identifier Type: -
Identifier Source: org_study_id
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