Condition category
Musculoskeletal Diseases
Date applied
20/12/2019
Date assigned
13/01/2020
Last edited
08/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
Suspended

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

14/06/2020

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

http://ibexinnovations.co.uk/

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

European Union, EC, EU

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

Editorial Notes

08/04/2020: Due to current public health guidance, recruitment for this study has been paused. 07/04/2020: The recruitment end date was changed from 14/03/2020 to 14/06/2020. 13/01/2020: The following changes were made to the trial record: 1. The protocol (not peer reviewed) was uploaded as an additional file. 2. The participant information sheets were uploaded as additional files. 30/12/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)