IBEX Trueview® Study, version 1.0
| ISRCTN | ISRCTN98160454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98160454 |
| IRAS number | 255317 |
| Secondary identifying numbers | CPMS 40376, IRAS 255317 |
- Submission date
- 20/12/2019
- Registration date
- 13/01/2020
- Last edited
- 30/12/2021
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Factory CRO
Prof. Bronkhorstlaan 10
Building 54
Bilthoven
3723 MB
Netherlands
| Phone | +31 30 229 2727 (ext 154) |
|---|---|
| r.derkman@factory-cro.com |
Study information
| Study design | Non-randomized; Interventional; Design type: Diagnosis, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN98160454_PIS_Phase 1_v1.2_25Feb2019.pdf |
| Scientific title | Evaluation of IBEX Trueview System to assess its effectiveness in producing image quality and bone mineral density measurement equivalent to conventional radiology |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Bone mineral density (BMD) as determined from the Trueview 1.0 software and DEXA system |
| Secondary outcome measures | n/a |
| Overall study start date | 12/11/2018 |
| Completion date | 14/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 190; UK Sample Size: 190 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/10/2019 |
| Date of final enrolment | 14/06/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Industry
Explorer 2 - Netpark Thomas Wright Way
Sedgefield
Stockton-On-Tees
TS21 3FF
United Kingdom
| Phone | +44 (0)1740 617799 |
|---|---|
| k.scott@ibexinnovations.co.uk | |
| Website | http://ibexinnovations.co.uk/ |
"ROR" |
https://ror.org/05cg6gz18 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 14/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.2 | 25/02/2019 | 13/01/2020 | No | Yes |
| Participant information sheet | version v1.2 | 25/02/2019 | 13/01/2020 | No | Yes |
| Protocol file | version v1.7 | 24/09/2019 | 13/01/2020 | No | No |
| Other publications | Evaluation of quantitative X-ray (QXR) method | 24/12/2021 | 30/12/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
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
Editorial Notes
30/12/2021: Publication reference added.
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)
