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Trial registered on ANZCTR


Registration number
ACTRN12619000632190
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
29/04/2019
Date last updated
29/04/2019
Date data sharing statement initially provided
29/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a photon-count spectral (Computed Tomography) CT for human imaging; evaluation of the first human trials of the MARS Spectral CT
Scientific title
Evaluation of MARS CT scan images in comparison to conventional CT images in patients and healthy volunteers
Secondary ID [1] 296272 0
None
Universal Trial Number (UTN)
U1111-1221-8675
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 312443 0
carotid atherosclerotic plaque 312444 0
arthritis 312445 0
fracture healing 312446 0
Condition category
Condition code
Musculoskeletal 310992 310992 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 310993 310993 0 0
Osteoarthritis
Musculoskeletal 310994 310994 0 0
Osteoporosis
Cardiovascular 310995 310995 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 310997 310997 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MARS Human CT in similar in design and operation at a conventional CT. The MARS CT scanner consists of an x-ray source and detector rotating around the participant. The only noticeable difference compared to conventional CT is a longer scan duration. Typical MARS scans will be approximately twenty minutes in duration.
The MARS Human CT scanner will be used to scan the extremities of up to 200 study participants. One group of up to 100 normal participants will have CT scans of part of the upper and lower extremities on the MARS CT and commercial GE CT scanner . Normal participants may have up to four total scans. Initially participants will be invited to one scan on the MARS scanner and one scan on the GE (or equivalent) scanner. The participant may be invited to have up to two additional scans using revised or newly developed scan protocols as part of a continuous design improvement process. The other group of up to 100 invited participants will be referred by Consultants in rheumatology, orthopeadics, and vascular surgery to have MARS CT of affected limbs in conjunction with standard radiologic imaging. These participants will have a variable number of scans based on consult recommendations.
MARS CT scanning will be performed by the MARS Bioimaging Ltd staff at the University of Canterbury, Christchurch, New Zealand, under direction of MCNZ registered physicians and/or registered technologist. Scans on the GE scanner will be performed at Lincoln University, Lincoln, New Zealand. Images of participants will be compared by radiologists and consultants using the technique of Visual Grading Analysis (VGA) to determine if there are differences between scanners or modalities.
Intervention code [1] 314229 0
Diagnosis / Prognosis
Comparator / control treatment
Conventional CT is defined as a commercially available approved CT scanner. One such unit is the GE HD750 scanner located at Lincoln University, Lincoln, New Zealand, Additional conventional CT scanners are located at Christchurch Hospital and Burwood Hospital, Christchurch, New Zealand
Control group
Active

Outcomes
Primary outcome [1] 319790 0
The primary outcome measurement will by statistical comparison of image quality as measured by a multiparametric Visual Grading Analysis for MARS and conventional CT
Timepoint [1] 319790 0
End of study; imaging 60-200 normal participants
Primary outcome [2] 319791 0
For normal and participant, the outcome is whether MARS images are at least as good as conventional CT images (normal participants) or standard medical imaging (clinical-invited participants). Radiologists and clinical consultants will grade the MARS and conventional CT on multiple parameters (resolution, image noise, diagnostic utility, etc) using an ordinal numeric scoring system; e.g. -1, 0, +1 which will analyzed using the technique of VGA.
Timepoint [2] 319791 0
End of study; imaging on up to 100 participants.
Secondary outcome [1] 369539 0
Nil
Timepoint [1] 369539 0
Nil

Eligibility
Key inclusion criteria
Normal participants: no know bone, joint, or vascular disease . Age forty and older.

Clinical participants: known bone, joint, or vascular disease, invited by consultant, age twenty-one and older
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age under forty for normal participants, age under twenty-one f or clinical participants. Pregnancy or suspected pregnancy of female participants

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The technique of Visual Grading Analysis (VGA) will be used. MARS Spectral CT images will be compared to conventional CT images of the same anatomic region and scored by radiologists for diagnostic features and image quality. Scores (-1,0,+1) will be assigned to each comparison and scores will be subject to statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 21418 0
New Zealand
State/province [1] 21418 0
Canterbury

Funding & Sponsors
Funding source category [1] 300865 0
Government body
Name [1] 300865 0
Ministry of Business, Innovation, and Employment
Country [1] 300865 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Prof. Anthony Butler
West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 300421 0
None
Name [1] 300421 0
Address [1] 300421 0
Country [1] 300421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301640 0
Southern Health and Disabilities Ethics Committee
Ethics committee address [1] 301640 0
Ethics committee country [1] 301640 0
New Zealand
Date submitted for ethics approval [1] 301640 0
25/10/2018
Approval date [1] 301640 0
10/04/2019
Ethics approval number [1] 301640 0
18/STH/221

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

Contacts
Principal investigator
Name 87630 0
Prof Anthony Butler
Address 87630 0
West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 87630 0
New Zealand
Phone 87630 0
+64 3 378 6359
Fax 87630 0
Email 87630 0
anthony.butler@marsbioimaging.com
Contact person for public queries
Name 87631 0
Anthony Butler
Address 87631 0
West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 87631 0
New Zealand
Phone 87631 0
+64 3 378 6359
Fax 87631 0
Email 87631 0
anthony.butler@marsbioimaging.com
Contact person for scientific queries
Name 87632 0
Anthony Butler
Address 87632 0
West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 87632 0
New Zealand
Phone 87632 0
+64 3 378 6359
Fax 87632 0
Email 87632 0
anthony.butler@marsbioimaging.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Limitations set by the participant consent form and restrictions on intellectual property owned by MARS Bioimaging, Ltd


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.