Earlier identification and enhanced understanding using three-dimensional images in the diagnosis of inflammatory arthritis
| ISRCTN | ISRCTN95817502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95817502 |
| IRAS number | 348373 |
| Secondary identifying numbers | CPMS 67177, Sponsor ref 23-26-32, Grant Code 10068051 |
- Submission date
- 02/10/2025
- Registration date
- 17/10/2025
- Last edited
- 17/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study will test a new type of scanner, the Adaptix Ortho350, to see how it compares to regular hand X-rays. It is the first time this scanner will be used with patients. The goal is to find out if this scanner can give better pictures and help healthcare professionals understand disease-related changes in bones and joints more clearly.
Who can participate?
Adult patients with inflammatory arthritis who require X-rays of the hands.
What does the study involve?
Each person will come for one visit that lasts no more than 45 minutes. During the visit, they will have a scan of both hands and fill out a short questionnaire. A specialist Radiologist will look at the Adaptix Ortho350 images and write a report for the team. These scan results will be sent to their usual healthcare team.
Before the scan, the procedure will be explained, and participants can ask questions. They will then sign a consent form. Their medical history will be checked using notes from their care team, which takes about 15 minutes. The scan itself takes around 5 minutes.
After the scan, participants will fill out a short questionnaire about how they felt about the experience. This takes about 10 minutes. Then they can leave. Their regular treatment will continue as normal.
The research team will also look at X-rays taken within 4 weeks of the scan to compare with the ADT images. Doctors will be asked if the ADT helped them make better decisions. No extra visits are needed.
What are the possible benefits and risks of participating?
Participants may help improve future arthritis imaging and care. They receive a new scan that may offer more detail than standard X-rays. Risks are low but include a small additional radiation dose from X-rays and may include mild discomfort during scanning or the sharing of medical data. Participation is voluntary, and regular treatment continues with their usual healthcare team.
Where is the study run from?
The Medical Imaging Centre at St Luke's Campus, University of Exeter, UK.
When is the study starting and how long is it expected to run for?
January 2023 to September 2026.
Who is funding the study?
1. Innovate UK
2. Adaptix Ltd, UK
Who is the main contact?
Professor Karen Knapp K.M.Knapp@exeter.ac.uk
Contact information
Public, Scientific, Principal investigator
South Cloister's, St Luke's Campus
Exeter
EX1 2LU
United Kingdom
 ORCID ID |
0000-0002-7360-0926 |
|---|---|
| Phone | +44 (0)7779690545 |
| K.M.Knapp@exeter.ac.uk |
Study information
| Study design | Feasibility diagnostic accuracy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Medical and other records, University/medical school/dental school |
| Study type | Diagnostic |
| Scientific title | Mobile 3D Imaging of Arthritis (Arthritis3D) |
| Study acronym | Arthritis3D |
| Study objectives | Adaptix Digital Tomosynthesis (ADT) for assessing the joints in patients with inflammatory arthritis will improve visualisation of joints and surrounding bone compared to standard 2D x-ray imaging. |
| Ethics approval(s) |
Approved 15/08/2025, Sheffield REC (Holland Drive, HRA Newcastle, NE2 4NQ, United Kingdom; +44 (0)2071048139; sheffield.rec@hra.nhs.uk), ref: 25/YH/0032 |
| Health condition(s) or problem(s) studied | Inflammatory arthritis |
| Intervention | Adaptix 3D x-ray imaging The study is a prospective, unblinded, comparative feasibility study of ADT imaging compared to standard radiographs, which will trial ADT in a clinical population for the first time. This is a one-arm trial including participants with inflammatory arthritis. All participants will undergo imaging as usual, with X-rays of their hands. In addition, a 3D image will be undertaken using the Adaptix Ortho350 digital tomosynthesis device. Acceptability of the new imaging will also be assessed using a questionnaire. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Adaptix Ortho360 |
| Primary outcome measure | Diagnostic performance, measured by comparison of ADT imaging to imaging as usual, at the time of clinical imaging |
| Secondary outcome measures | 1. Joint space measurement, assessed using ADT and imaging as usual, at the time of clinical imaging 2. Bone density, measured using ADT, at the time of clinical imaging 3. Bone microarchitecture, measured using ADT, at the time of clinical imaging 4. Image quality of ADT compared to projection radiographs using signal-to-noise and contrast-to-noise ratio, at the time of clinical imaging 5. Patient acceptability, measured using an acceptability questionnaire at baseline 6. Clinician acceptability, measured using feedback on image quality at the end of recruitment |
| Overall study start date | 30/01/2023 |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target number of participants | 30 |
| Key inclusion criteria | Inflammatory arthritis requiring X-rays of the hands |
| Key exclusion criteria | 1. Unable to keep hands still for 15 seconds 2. Women who are pregnant or planning to become pregnant 3. Unable to provide informed consent 4. People who do not have sufficient proficiency in English language to read the participant information sheet or provide informed consent |
| Date of first enrolment | 22/09/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Barrack Road
Exeter
EX2 5DW
United Kingdom
South Cloisters
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
Sponsor information
University/education
Research Governance, Ethics and Compliance
University Corporate Services , University of Exeter
G14, Lafrowda House, St Germans Road
Exeter
EX4 6TJ
England
United Kingdom
| Phone | +44 (0)1392724133 |
|---|---|
| res-sponsor@exeter.ac.uk | |
| Website | https://www.exeter.ac.uk/departments/cgr/researchethics/ |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UK Research and Innovation Innovate UK, innovateuk
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during this study are not expected to be made available because they link directly to clinical care and form a feasibility trial dataset only. |
Editorial Notes
17/10/2025: Study's existence confirmed by Health Research Authority (HRA) (UK).
