Plain English Summary
Background and study aims
Digital radiography is widely used as a way of obtaining images of the internal structures of the body using X-rays. A major drawback of using X-rays is that they can be scattered by thicker body parts. This scatter significantly reduces image quality and is currently dealt with by using a physical anti-scatter grid (ASG) which prevents scattered X-rays from reaching the X-ray detector/camera. Anti-scatter grids also absorb a portion of the direct X-rays required to form a useful image and so the patient dose needs to be increased to compensate. Removing the need for an ASG would potentially allow lower dose examinations to take place. IBEX Innovations Limited (IBEX), a local high-technology business based in Sedgefield, has developed a novel solution that offers the potential to remove the effects of scattered X-rays without the need for an ASG. The aim of the study is to demonstrate the effectiveness of the IBEX Trueview® software.
Who can participate?
Phase 1: Adult aged 50 years or above attending for a DEXA scan of Neck of Femur (for measurement of bone mineral density)
Phase 2: Adult aged 18 years or above, attending orthopaedic outpatient’s clinic and requiring plain radiographs of wrist or shoulder or pelvis
What does the study involve?
Participants in phase 1 will have their X-ray taken as usual and it will be processed using the Trueview® software. If the X-rays require an ASG , participants will be asked to have a second identical set of X-rays taken without the ASG in place.
Participants in phase 2 will have an additional X-ray scan of their pelvis which will be processed using the Trueview® software.
What are the possible benefits and risks of participating?
Benefits:
There will be no clinical benefit to the participants, but they will be contributing to the development and adoption of a technology that has the future potential to:
-Improve diagnostic X-ray image quality
-Streamline radiographic assessments and improve efficiency
-Provide additional diagnostic information to enable early detection of bone health conditions
Risks:
The only risk for patients is associated with the additional radiation exposure imposed by additional radiographs. As with all medical procedures, there is also a possibility for unanticipated risks to occur, although every effort has been taken to ensure that patient safety is of the highest importance.
Where is the study run from?
James Cook University Hospital, UK
When is the study starting and how long is it expected to run for?
October 2019 to June 2020
Who is funding the study?
1. European Commission
2. National Institute for Health Research (NIHR), UK
3. Ibex Innovations, UK
Who is the main contact?
Roel Derkman
r.derkman@factory-cro.com
Trial website
Contact information
Type
Public
Primary contact
Mr Roel Derkman
ORCID ID
Contact details
Factory CRO
Prof. Bronkhorstlaan 10
Building 54
Bilthoven
3723 MB
Netherlands
+31 30 229 2727 (ext 154)
r.derkman@factory-cro.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 40376, IRAS 255317
Study information
Scientific title
Evaluation of IBEX Trueview System to assess its effectiveness in producing image quality and bone mineral density measurement equivalent to conventional radiology
Acronym
Study hypothesis
The primary objective of the study is to demonstrate the effectiveness of the Trueview software in obtaining bone mineral density data at an accuracy equivalent to that of a DEXA on a standard DR system without negatively impacting the diagnostic image quality of the radiograph. To do so the study consists of two seperate phases:
Phase 1 - To demonstrate that Trueview® generates a measure of bone health to the same accuracy as a dedicated DEXA system
Phase 2 - To demonstrate that the Trueview® technology generates X-ray images to at least the same quality as an existing X-ray system
Ethics approval
Approved 27/12/2018, Study North East - Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048026; nrescommittee.northeast-tyneandwearsouth@nhs.net), ref: 18/NE/0368
Study design
Non-randomized; Interventional; Design type: Diagnosis, Imaging
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Disorders of bone density and structure
Intervention
Participants in Phase 1 will be asked to consent to the processing of their radiographs (X-ray photos) using the Trueview® technology. In cases where their standard set of radiographs requires an ASG to be used, they will be asked to have a second identical set of radiographs taken without the ASG in place. The additional assessment would take place immediately after their first set of radiographs and will add a small amount of time onto their visit (~5 mins). The additional scan will only be used to assess the performance of the technology and their scheduled assessment will still be made using the standard set of exposures as per standard clinical practice.
Participants in Phase 2 will be asked to attend the radiology department at James Cook University Hospital for an additional X-ray scan of their pelvis. The additional assessment will take place immediately after their scheduled DEXA scan and will be taken using a standard digital radiography system. The image will then be processed using the Trueview® software to obtain a second measure of their bone health for comparison. The additional scan will take approximately the same amount of time the DEXA scan.
Participation in the study begins once participants give their consent when they attend for their scheduled radiography assessment and ends once the radiographic assessments are complete. Participants will not be contacted for any further information in relation to this study.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Bone mineral density (BMD) as determined from the Trueview 1.0 software and DEXA system
Secondary outcome measures
n/a
Overall trial start date
12/11/2018
Overall trial end date
14/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who meet the following criteria will be considered eligible for Phase 1 of study:
1. Caucasian male or female, at least 50 years of age attending for a DEXA scan of Neck of Femur (for measurement of bone mineral density)
2. Patient able to comprehend and sign the informed consent prior to enrolment in the study
Patients who meet the following criteria will be considered eligible for Phase 2 of study:
1. Male or female, 18 years of age or over, attending orthopaedic outpatient’s clinic and requiring plain radiographs of wrist or shoulder or pelvis
2. Patient able to comprehend and sign the informed consent prior to enrolment in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 190; UK Sample Size: 190
Participant exclusion criteria
Phase 1:
1. Women who are pregnant or are breastfeeding
2. Concurrent participation in another experimental intervention or drug study
3. Has an implant or other radio-opaque foreign body in the location of the assessment
4. Unwilling or unable to provide informed consent
Phase 2:
1. Women who are pregnant or are breastfeeding
2. Concurrent participation in another experimental intervention or drug study
3. Unwilling or unable to provide informed consent
4. Currently wearing a cast on assessment site that is not intended to be removed prior to radiographic assessment
5. Has an implant or other radio-opaque foreign body in the location of the assessment
Recruitment start date
14/10/2019
Recruitment end date
14/03/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
James Cook University Hospital
Marton Rd
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
Ibex Innovations (United Kingdom)
Sponsor details
Explorer 2 - Netpark Thomas Wright Way
Sedgefield
Stockton-On-Tees
TS21 3FF
United Kingdom
+44 (0)1740 617799
k.scott@ibexinnovations.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
European Commission
Alternative name(s)
European Union, EU, EC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Ibex Innovations
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
14/06/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN98160454_PROTOCOL_CIP v1.7_24Sep2019.pdf uploaded 13/01/2020
- ISRCTN98160454_PIS_Phase 1_v1.2_25Feb2019.pdf uploaded 13/01/2020
- ISRCTN98160454_PIS_Phase 2_v1.2_25Feb2019.pdf uploaded 13/01/2020