Advanced Medical Imaging in Subpatent Malaria: a pilot study

Not Applicable

Completed

• Conditions: Experimental subpatent malaria infection; Infection - Other infectious diseases

• Registration Number: ACTRN12616001458426
• Lead Sponsor: Clinical Network Services (local sponsor)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-19
• Study Completion: 2016-12-13
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 2

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.)[Primary outcome 1 Timepoint: baseline and estimated 7-9 days following low dose malaria inoculation.<br>];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.)<br>[Primary outcome 2 Timepoint: baseline and estimated 7-9 days following low dose malaria inoculation.]

Secondary Outcome Measures

Name	Time	Method
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.<br>[Secondary Outcome 3 Timepoint: estimated 7-9 days following low dose malaria inoculation.<br>]