Infection and Inflammatory Reaction Due to Internal Joint ProsthesisNCT02855190
Comparative Study With Different Tracers (18F-FDG and 68Gallium Citrate) in the Diagnosis of Periprosthetic Joint Infection
A study testing 68Ga-citrate and 18F-FDG PET scans in people with Infection and Inflammatory Reaction Due to Internal Joint Prosthesis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Infection and Inflammatory Reaction Due to Internal Joint Prosthesis
- What is being tested?
- 68Ga-citrate and 18F-FDG PET scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically-proved or -suspicious periprosthetic joint infection and treated with two-stage exchange arthroplasty
- Age equals or more than 20 years old
- Willing to sign the informed consent
Who cannot join
- 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.
- Unable to give informed consent
- Patient who is pregnant or lactating
- Unwilling to use contraceptives during nuclide medicine examinations.
- Allergy history to FDG or Ga68-citrate, significant abnormal lab data, and high risk to conduct examination after evaluations of PI.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital at Linkou
Taoyuan, 333
Jing-Ren Tseng, MD, +886- 3281200 ext. 2744, drtsengjr@gmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- 68Ga-citrate and 18F-FDG PET scans
- Keywords
- Ga68-citrate, FDG, PET/MR and PET/CT, Periprosthetic joint infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-citrate and 18F-FDG PET scansOther
68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-citrate and 18F-FDG PET scans | Experimental | 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. Receives: Other: 68Ga-citrate and 18F-FDG PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infection and Inflammatory Reaction Due to Internal Joint ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzu-Chen Yen, Chang Gung Memorial Hospital
- Investigators
- Yen Tzu-Chen, MD,PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855190
- Sponsor's protocol ID
- 103-7226A
- Status last verified
- Jun 2018
- First submitted
- 28 Jul 2016
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 21844889Mohler 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.
PubMed 22956807Picchio 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.
PubMed 22448197Schwarzenbock 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.
PubMed 22448198Beer 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.
PubMed 20599424Umbehr 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.
PubMed 23628493Wetter 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.
PubMed 23462678Abuzallouf 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.
PubMed 15126770Souvatzoglou 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.
PubMed 23703457Tseng 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.
PubMed 30607646
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02855190
- Acronym / sponsor ID
- 103-7226A
- Keywords
- Ga68-citrate, FDG, PET/MR and PET/CT, Periprosthetic joint infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-citrate and 18F-FDG PET scans | Experimental | Other: 68Ga-citrate and 18F-FDG PET scansThe 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. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinically-proved or -suspicious periprosthetic joint infection and treated with two-stage exchange arthroplasty
- Age equals or more than 20 years old
- Willing to sign the informed consent
Key exclusion criteria (5 listed)
- 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.
- Unable to give informed consent
- Patient who is pregnant or lactating
- Unwilling to use contraceptives during nuclide medicine examinations.
- Allergy history to FDG or Ga68-citrate, significant abnormal lab data, and high risk to conduct examination after evaluations of PI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-citrate and 18F-FDG PET scans68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations | Other | 68Ga-citrate and 18F-FDG PET scans |
Primary outcome
sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Results publication: PubMed 21844889Bauman 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.
- Results publication: PubMed 22956807Mohler 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.
- Results publication: PubMed 22448197Picchio 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.
- Results publication: PubMed 22448198Schwarzenbock 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.
- Results publication: PubMed 20599424Beer 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.
- Results publication: PubMed 23628493Umbehr 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.
- Results publication: PubMed 23462678Wetter 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.
- Results publication: PubMed 15126770Abuzallouf 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.
- Results publication: PubMed 23703457Souvatzoglou 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.
- Derived from this study: PubMed 30607646Tseng 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen Tzu-Chen, MD,PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-citrate and 18F-FDG PET scans in people with Infection and Inflammatory Reaction Due to Internal Joint Prosthesis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen Tzu-Chen, MD,PhD (03-328-1200 ext. 2744, yen1110@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of the two PET/CT tracers (18F-FDG and 68Gallium citrate) in detecting periprosthetic joint infection (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855190, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.