Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000479808
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
1/05/2012
Date last updated
11/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Fluorodeoxyglucose Positron Emission Tomography (F18-FDG PET) scans in infection of the extremities
Scientific title
Evaluation of F18 FDG PET/CT in infection of the extremities.
Secondary ID [1] 280370 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection of the extremities 286346 0
Condition category
Condition code
Infection 286591 286591 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following study enrolment each patient will undergo a FDG PET-CT in addition to a labelled leukocyte study +/- bone scan. The labelled leukocyte study +/- bone scan are routine clinical care, and the FDG PET-CT scan of the peripheries is in addition to routine care. The routine care options for participants will differ on a case by case basis, and are listed in the Comparator/Control field below.The white cell scans and the FDG PET-CT scan will be performed within a week of each other. Patients will be followed for up to 3 months to record subsequent treatment regimens: antibiotics, surgery, radiological and clinical responses to therapy and biopsy results when performed.

Patients will be required to fast for 4-6 hours An intravenous cannula will be inserted into a peripheral vein and the blood sugar level (BSL) recorded. If fasting BSL > 11.1mmol/l the reporting PET physician will decide if study is to proceed or be re-scheduled. Aporoximately 4 MBq/kg of 18F-FDG (maximum 250 MBq) will be administered intravenously. Patient will rest quietly for one hour. Mobilisation is discouraged during the ‘uptake phase’.
PET-CT imaging will be performed on Siemens PET-CT, one hour following FDG administration, over 2-3 bed positions with CT field of view limited to area of interest in extremities. Image reconstruction will include CT attenuation correction.
Intervention code [1] 284741 0
Diagnosis / Prognosis
Comparator / control treatment
All participants will undergo one of the current routine care options listed below but all participants will undergo the FDG PET-CT scan intervention.
Bone scan (routine care)
Via a peripheral intravenous cannula approximately 1000 MBq 99mTc-HDP (dose will be adjusted to patient weight) will be injected into the patient. Dynamic images of the extremities are obtained after tracer injection, followed by bloodpool static images for 2 minutes on a gamma camera. At least 6 hours after injection, static images of the extremities will be obtained for 5 to 15 minutes, supplemented by Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) at reporting clinician’s discretion (30 minutes).

Oxine Labelled Autologous White Blood Cell (WBC) study (routine care). Patient’s white blood cells (WBC’s) are labelled with 10-20MBq of Indium-111 oxine, Then 20-24 hrs after re-injection of patient's Indium111 Oxine Labelled WBCs in a peripheral vein, static images are obtained over 10-15 minutes supplemented by SPECT/CT at reporting clinician’s discretion (40 minutes).

Dual Technetium 99 (99m-Tc) HDP bone scan and Indium 111 (111In) Oxine Labelled White Blood Cell (WBC) (routine care). A blood sample is taken from the patient and white cells are labelled with 10-20 MBq of Indium-111 oxine and re-injected back into a peripheral vein. Approximately 1000 MBq 99mTc-HDP (dose adjusted to patient weight) will be administered intravenously and dynamic images of the extremities are obtained. At 20-24 hrs after 99mTc-HDP and autologous 111In-labelled leukocyte injection, dual tracer planar images with similar incidence to the delayed bone scan are obtained during 10-15 minutes on SPECT/CT of the extremities (40 minutes) at reporting clinician’s discretion.

99mTc HMPAO labelled Autologous White Blood Cell (routine care). Usually performed 48 hours after a bone scan. The patient’s blood will be taken and WBC’s will be labelled with 200 - 250 MBq of 99mTc-HMPAO, At 4 hours after re-injection with the autologous labelled white cells, static images of the extremities are obtained for 5 to 15 minutes, supplemented by SPECT/CT (40 minutes).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287011 0
Primary Outcome 1 On PET-CT focal accumulation of F18 FDG in bone and FDG SUVmax in sites of osteomyelitis at anatomically comparable sites to those identified by the bone scan or white cell scan.
Timepoint [1] 287011 0
Baseline
Primary outcome [2] 287012 0
Primary Outcome 2: Clinical/microbiological confirmation of osteomyelitis based on clinical follow-up or biopsy results.
Timepoint [2] 287012 0
Follow-up over three months
Secondary outcome [1] 297196 0
Image misregistration events
Timepoint [1] 297196 0
At baseline The technologists and reporting physicians will look at the images obtained to assess if there is misregistration. If it is the case and if the patient agrees the scan will be performed a second time.
Secondary outcome [2] 297197 0
Time (days) between request received and completion of imaging
Timepoint [2] 297197 0
At baseline. The date of request is written by the requesting physician on the request form and the date of completion of images is written by the technologists on their worksheet and the screensaves of the study.
Secondary outcome [3] 297198 0
Imaging time (minutes) total time patient on camera
Timepoint [3] 297198 0
At baseline. This data is obtained from the technologist(s) who performs the images in the Nuclear Medicine Department and complete a technologist worksheet
Secondary outcome [4] 297199 0
Number of rescheduled or failed tests, failed IV access, BSL>11.1 mmols etc.
Timepoint [4] 297199 0
At baseline. This is obtained from the technologists who complete the technologist worksheet at the time of scanning the patient. The research nurse may also inform the technologists if the study needs to be rescheduled.
Secondary outcome [5] 297200 0
Patient comfort score based on the answers to the participant questionnaire
Timepoint [5] 297200 0
At baseline. The study participants will select options on the questionnaire consistent with their level of comfornt during the procedures.
Secondary outcome [6] 297201 0
Image quality score (rate of score greater or equal to 3)
Timepoint [6] 297201 0
At baseline. Case report forms will record image quality for FDG PET-CT and for white cell scan.
Secondary outcome [7] 297202 0
Inter-reporter agreement
Timepoint [7] 297202 0
At baseline. The case reports forms for FDG PET-CT and white cell scan. Two reporting physicians will be randomly assigned to complete the case report form in isolation. For each scan, the case report forms will be compared to each other.

Eligibility
Key inclusion criteria
Suspected osteomyelitis/septic arthritis of the extremities
Able to undergo study procedures
Able to provide informed consent
Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years
Pregnant or lactating at the time of SPECT-CT and PET-CT scan/s
Unable to provide informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study compares for each patient a new imaging technique: FDG PET-CT to the technique used in routine clinical practise: white cell scan. The white cell can be labelled with either 111-Indium or 99m-technetium.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2012
Actual
15/05/2012
Date of last participant enrolment
Anticipated
Actual
5/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285148 0
Hospital
Name [1] 285148 0
Department of Nuclear Medicine / WA PET Service
Country [1] 285148 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue,
Nedlands,
Perth
Western Australia
6009
Country
Australia
Secondary sponsor category [1] 284018 0
None
Name [1] 284018 0
Address [1] 284018 0
Country [1] 284018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287171 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 287171 0
Ethics committee country [1] 287171 0
Australia
Date submitted for ethics approval [1] 287171 0
Approval date [1] 287171 0
08/12/2011
Ethics approval number [1] 287171 0
2011-019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34099 0
A/Prof Roslyn Francis
Address 34099 0
Department of Nuclear Medicine/WA PET Service
Level 1, G Block
Sir Charles Gairdner Hospital
Hospital Ave,
Nedlands, WA, Perth, 6009
Country 34099 0
Australia
Phone 34099 0
+61893462322
Fax 34099 0
Email 34099 0
Ros.Francis@health.wa.gov.au
Contact person for public queries
Name 17346 0
Elaine Campbell
Address 17346 0
Department of Nuclear Medicine /WA PET Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 17346 0
Australia
Phone 17346 0
+61 8 9346 2322
Fax 17346 0
+61 8 9346 3610
Email 17346 0
Elaine.Campbell@health.wa.gov.au
Contact person for scientific queries
Name 8274 0
Tatiana Segard
Address 8274 0
Department of Nuclear Medicine / WA PET Service
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 8274 0
Australia
Phone 8274 0
+61 8 9346 2322
Fax 8274 0
+61 8 9346 3610
Email 8274 0
Tatiana.Segard@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.