Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001166864
Ethics application status
Approved
Date submitted
25/10/2012
Date registered
2/11/2012
Date last updated
11/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between Gallium-68 citrate Positron Emission Tomography (PET-CT) and Gallium-67 citrate Single Photon Emission Computed Tomography (SPECT-CT) for infection imaging
Scientific title
Comparison between Gallium-68 citrate Positron Emission Tomography (PET-CT) and Gallium-67 citrate Single Photon Emission Computed Tomography (SPECT-CT) in participants with suspected bone and joint infections or fever of unknown origin.
Secondary ID [1] 281437 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection of bone and/or joint 287696 0
Fever of unknown origin. 287753 0
Condition category
Condition code
Infection 288035 288035 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single Gallium -68 citrate PET-CT will be performed in addition to the routine Gallium -67 SPECT-CT study.
In participants with fever of unknown origin, approximately 98 MBq of Ga-68 citrate will be administered intravenously. After a minimum of 60 minutes following injection, whole body PET-CT imaging will be performed on Siemens PET-CT, image reconstruction will include CT attenuation correction.
For participants with suspected bone/joint infection approximately 135 MBq of Ga-68 citrate will be administered intravenously. After a minimum of 60 minutes following injection, PET-CT imaging of the region of interest will be performed on Siemens PET-CT, image reconstruction will include CT attenuation correction.
The Gallium -68 citrate PET-CT and the Gallium -67 SPECT-CT scan will be performed ideally within 48-72 hours 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.
Intervention code [1] 285943 0
Diagnosis / Prognosis
Comparator / control treatment
The control treatment is the current standard of care, Gallium -67 SPECT-CT. 150 MBq of Ga-67 citrate will be administered intravenously.
48-72 hours after tracer injection whole body or localised planar images will be performed with a 256 x 1024 matrix and at 5 cm/min. SPECT-CT (either 1 or 2 SPECT-CT) of the suspected site of infection clinically or region of abnormal activity on the whole body or localised planar images will be obtained with 48 views of 35 sec on the Siemens Symbia gamma camera (or equivalent) with Medium Energy Collimators. SPECT-CT field of view to be determined by Nuclear Medicine Physician as per normal clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 288240 0
To compare Ga-68 citrate PET-CT with Ga-67 citrate SPECT-CT for diagnosing infection in patients with suspected bone/joint infection or with PUO
This will be assessed based on the analysis of:
 Site(s) of Ga-67 uptake on SPECT-CT,
 Site(s) of Ga-68 uptake on PET-CT.
In case of disagreement between the specialists in Nuclear Medicine and PET-CT analysing the
studies, the final diagnosis will be allocated based on biopsy results, results of additional imaging (CT,
MRI), duration of antibiotic therapy, and relevant correspondence This will be independently reviewed
by an Infectious diseases specialist, who will be blinded to the Ga-68 PET scan results.
Timepoint [1] 288240 0
At baseline
Primary outcome [2] 288241 0
To assess image quality and reporter confidence with Ga-68 PET-CT
Image quality scores, reporter confidence scores and inter-reporter agreement for Ga-68 citrate PETCT
will be compared with Ga-67 citrate SPECT.
Timepoint [2] 288241 0
At baseline
Secondary outcome [1] 299682 0
To evaluate the cost-benefit of routine Ga-68 citrate PET-CT compared to Ga-67 citrate SPECT-CT in
the management of patients with suspected bone/joint infection or PUO.
The following data will be used to perform the cost-benefit analysis:
 Time between request received and completion of imaging (days/hours)
 Time between injection and completion of imaging (hours/minutes)
 Time between completion of Ga-67 citrate imaging and inpatient discharge (days/hours)
 Imaging acquisition time (minutes): total time patient is on camera
 Estimated radiation dose to patient
 Patient comfort score based on the answers to the participant questionnaire
 Referring physician questionnaire - impact of imaging test on discharge planning. This will be
incorporated into the estimation of cost savings if there is a projected reduction in inpatient
days in hospital.
An estimate of financial cost of Ga-68 PET-CT compared to Ga-67 SPECT-CT will be made based on
the length of inpatient stay in hospital, and the cost of the imaging procedure. For Ga-67 SPECT-CT
the actual inpatient stay will be used and for Ga-68 PET-CT an estimate of inpatient stay will be made
based on time between Ga-68 PET-CT request and completion of imaging.
Timepoint [1] 299682 0
3 months after commencement

Eligibility
Key inclusion criteria
Presents with PUO or suspected bone/joint infection
Able to undergo study procedures
Able to provide informed consent
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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/11/2012
Actual
29/11/2012
Date of last participant enrolment
Anticipated
Actual
25/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3111 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 3112 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 5893 0
6009

Funding & Sponsors
Funding source category [1] 286204 0
Government body
Name [1] 286204 0
State Health Research Advisory Council (SHRAC)
Country [1] 286204 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] 285014 0
None
Name [1] 285014 0
Address [1] 285014 0
Country [1] 285014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288277 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 288277 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, Perth
Western Australia 6009
Ethics committee country [1] 288277 0
Australia
Date submitted for ethics approval [1] 288277 0
Approval date [1] 288277 0
20/09/2012
Ethics approval number [1] 288277 0
2012-029
Ethics committee name [2] 288278 0
Royal Perth Hospital Ethics
Ethics committee address [2] 288278 0
Level 5, Colonial House
Royal Perth Hospital
Murray Street
Perth WA 6000
Ethics committee country [2] 288278 0
Australia
Date submitted for ethics approval [2] 288278 0
Approval date [2] 288278 0
19/10/2012
Ethics approval number [2] 288278 0
RA-12/020
Ethics committee name [3] 288279 0
University of Western Australia Human Research Ethics
Ethics committee address [3] 288279 0
Research Services
35 Stirling Highway, Crawley, WA 6009
Ethics committee country [3] 288279 0
Australia
Date submitted for ethics approval [3] 288279 0
Approval date [3] 288279 0
Ethics approval number [3] 288279 0
RA/4/1/5677

Summary
Brief summary
This study aims to compare Gallium-68 citrate PET-CT with Gallium-67 citrate SPECT-CT, the current standard of care, for diagnosis in patients with suspected bone/joint infection or with pyrexia of unknown origin (PUO).
Image quality and reporter confidence with Ga-68 PET-CT will be assessed and the cost-benefit of routine Ga-68 citrate PET-CT compared to Ga-67 SPECT-CT will be evaluated. On completion of the study an informed recommendation for future infection imaging protocols for bone/joint infections and PUO will be made based on clinical efficacy and cost-benefit analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34871 0
A/Prof Roslyn Francis
Address 34871 0
Department of Nuclear Medicine/WA PET Service
Level 1, G Block
Sir Charles Gairdner Hospital
Nedlands, WA, Perth 6009
Country 34871 0
Australia
Phone 34871 0
+61893462322
Fax 34871 0
Email 34871 0
[email protected]
Contact person for public queries
Name 18118 0
Ms Elaine Campbell
Address 18118 0
Department of Nuclear Medicine /WA PET Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 18118 0
Australia
Phone 18118 0
+61 8 9346 2322
Fax 18118 0
+61 8 9346 3610
Email 18118 0
[email protected]
Contact person for scientific queries
Name 9046 0
Dr Tatiana Segard
Address 9046 0
Department of Nuclear Medicine / WA PET Service
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 9046 0
Australia
Phone 9046 0
+61 8 9346 2322
Fax 9046 0
+61 8 9346 3610
Email 9046 0
[email protected]

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

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