Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001458426
Ethics application status
Approved
Date submitted
14/10/2016
Date registered
19/10/2016
Date last updated
16/12/2020
Date data sharing statement initially provided
16/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Advanced Medical Imaging in Subpatent Malaria: a pilot study
Scientific title
Function Nuclear Medicine Imaging in Subpatent Malaria: a pilot study for specific parallel addition to the induced blood stage malaria model challenge trial QP15C20.
Secondary ID [1] 290335 0
P2196
Universal Trial Number (UTN)
Trial acronym
Linked study record
NCT02867059

Health condition
Health condition(s) or problem(s) studied:
Experimental subpatent malaria infection 300605 0
Condition category
Condition code
Infection 300455 300455 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be recruited from an independent clinical trial that involve induced blood stage malaria (IBSM) challenge – QP15C20. As part of these independent clinics trials participants are inoculated with a low dose of malaria which is subsequently closely monitored in the community for 8 to 10 days prior to treatment. Based on the level of malaria detected in these trials participants are then admitted to the trial unit (confinement period) for administration of an anti-malarial agent to treat the induced infection and determine the efficacy of this agent. If participants are recruited into this study they will have an observational PET/MRI scan. The timing of this scan will work in accordance to the malaria inoculation schedule of the independent clinical trial. Participants will receive a whole body PET/MRI scan and dedicated brain MRI within approximately one week prior to inoculation and on one to two days prior to confinement with peak parasitaemia post inoculation. Scans will be performed on the Biograph mMR PET/MRI system after the intravenous infusion of the standard radiotracer 2-(18F) fluor-deoxy-D-glucose(FDG) (18F FDG) and MAGNETOM Prisma 3T MRI system. Collected images will be reviewed and reported by experienced radiologists specialising in MRI and nuclear medicine reporting. Quantification of 18F FDG uptake measurements will be established for intra-individual scans using Patlak model analysis and semi quantitative SUV measurement with reference to an 18F FDG external control. An estimated dose of 4.5MBq per kg (based on screening weight) 18F FDG is to be administered by infusion (minimum dose 90MBq, maximum dose 400MBq).
Intervention code [1] 296147 0
Diagnosis / Prognosis
Comparator / control treatment
Pre inoculation imaging will serve as a control for post inoculation imaging in this prospective observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299891 0
Primary Outcome 1: Intra-individual PET tracer uptake changes in regions of interest post malaria inoculation (prospective regions of interest include: spleen, bone marrow, brian and skeletal muscle.)
Timepoint [1] 299891 0
Primary outcome 1 Timepoint: baseline and estimated 7-9 days following low dose malaria inoculation.
Primary outcome [2] 299892 0
Primary Outcome 2: Intra-individual MRI imaging changes in regions of interest post malaria inoculation (prospective regions of interest include: spleen, bone marrow, brian and skeletal muscle.)
Timepoint [2] 299892 0
Primary outcome 2 Timepoint: baseline and estimated 7-9 days following low dose malaria inoculation.
Secondary outcome [1] 328403 0
Secondary Outcome 3: The impact of early malaria infection on glucose metabolism will be evaluated based on the the biodistribution and degree of uptake of the PET tracer.
Timepoint [1] 328403 0
Secondary Outcome 3 Timepoint: estimated 7-9 days following low dose malaria inoculation.

Eligibility
Key inclusion criteria
*Provide signed and dated informed consent form
*Able to lie supine and still for duration of image acquisition
*Participating in induced blood stage malaria human challenge model study
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Known allergic reactions to components of the study radiotracer 18F FDG
*Fasted blood glucose elevated above the normal range (BSL >6.0mmol/L)
*Failure to meet/provide the standard MRI checklist requirements
*Claustrophobia precluding image acquisition
*Significant previous radiation exposure as defined (lifetime exposure):
*Any fluoroscopic imaging (e.g. coronary angiography)
a. Any nuclear medicine imaging (e.g. myocardial perfusion scan)
b. Greater than one previous CT scan
c. Note: previous plain film X-rays and mammography are acceptable

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
subpatent malaria. The population will comprise of approximately eight adult participants. This population size has been estimated based on the clinical experience of the subinvestigators.
It is expected that this study will be hypothesis generating.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/10/2016
Actual
24/10/2016
Date of last participant enrolment
Anticipated
31/10/2016
Actual
16/11/2016
Date of last data collection
Anticipated
1/12/2016
Actual
13/12/2016
Sample size
Target
2
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14491 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 294718 0
Commercial sector/Industry
Name [1] 294718 0
Medicines for Malaria Venture
Country [1] 294718 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Clinical Network Services (local sponsor)
Address
88 Jepson Street
Toowong
Queensland
Q4066
Country
Australia
Secondary sponsor category [1] 293563 0
Commercial sector/Industry
Name [1] 293563 0
Medicines for Malaria Venture
Address [1] 293563 0
PO Box 1826
20, Route de Pre-Bois
1215 Geneva 15
Country [1] 293563 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296138 0
QIMR-Berghoger Medical Research Institute Human Research Ethics Committee
Ethics committee address [1] 296138 0
Ethics committee country [1] 296138 0
Australia
Date submitted for ethics approval [1] 296138 0
01/10/2016
Approval date [1] 296138 0
13/10/2016
Ethics approval number [1] 296138 0
P2196

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

Contacts
Principal investigator
Name 69694 0
Prof James McCarthy
Address 69694 0
Clinical Tropical Medicine Laboratory
QIMR-Berghofer
300 Herston Road
Heston
Queensland 4029
Country 69694 0
Australia
Phone 69694 0
+617 3845 3636
Fax 69694 0
Email 69694 0
j.mccarthy@uq.edu.au
Contact person for public queries
Name 69695 0
John Woodford
Address 69695 0
Clinical Tropical Medicine Laboratory
QIMR-Berghofer
300 Herston Road
Heston
Queensland 4029
Country 69695 0
Australia
Phone 69695 0
+61736468111
Fax 69695 0
Email 69695 0
john.woodford@qimrberghofer.edu.au
Contact person for scientific queries
Name 69696 0
John Woodford
Address 69696 0
Clinical Tropical Medicine Laboratory
QIMR-Berghofer
300 Herston Road
Heston
Queensland 4029
Country 69696 0
Australia
Phone 69696 0
+61736468111
Fax 69696 0
Email 69696 0
john.woodford@qimrberghofer.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
Dimensions AIPositron emission tomography and magnetic resonance imaging in experimental human malaria to identify organ-specific changes in morphology and glucose metabolism: A prospective cohort study2021https://doi.org/10.1371/journal.pmed.1003567
N.B. These documents automatically identified may not have been verified by the study sponsor.