SacroiliitisTOMOS SINCT03689881
Value of Tomosynthesis for the Detection of Sacro-iliitis (TOMOS SI)
A study testing Tomosynthesis of SI joints in people with Sacroiliitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Spondyloarthropathies (SpAs) are chronic inflammatory diseases encompassing ankylosing spondylitis, psoriatic arthritis, reactive arthritis, enteropathic arthropathy, and undifferentiated SpA. In 2001, the estimated prevalence of SpA was 1.5% worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- Tomosynthesis of SI joints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over referred for suspected sacroiliitis.
- Patients who have entered into their participation agreement by signing the informed consent form.
- Patient affiliated to a social security scheme or beneficiary.
Who cannot join
- Pregnant or lactating women.
- Vulnerable people according.
- Major people placed under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Imaging department- University hospital
Montpellier, 34295
Sophie Lefebvre, +33 4 67 33 86 07, s-lefebvre@chu-montpellier.fr
Celine Engrand, +33 4 67 33 86 07, c-engrand@chu-montpellier.fr
About this study
Official title: Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study
Spondyloarthropathies (SpAs) are chronic inflammatory diseases encompassing ankylosing spondylitis, psoriatic arthritis, reactive arthritis, enteropathic arthropathy, and undifferentiated SpA.
In 2001, the estimated prevalence of SpA was 1.5% worldwide. Sacroiliitis is a condition caused by inflammation within the sacroiliac joint. It is the most frequent damage of SpA depicted at imaging evaluation.
Read more
Conventional radiography (X-ray) is usually used to depict the structural changes associated with sacroiliitis.
However further evaluation often requires additionnal computed tomography (CT).
Tomosynthesis is an Xray-based imaging technology which allows reconstruction of multiple section images from a set of projection images acquired as the x-ray tube moves along a prescribed path. The advantagee of tomosynthesis is the significant reduction of radiation dose exposure compared to CT Tomosynthesis is currently used in the field of breast imaging and pneumology. Very few studies have examined the value of tomosynthesis for osteoarticular imaging.
The study aims at evaluating the diagnostic performances of tomosynthesis as compared to standard X-ray and CT, in patients with a clinical suspicion of sacroiliitis.
the investigators hypothesize that tomosynthesis is superior to conventional radiography for detection of sacroiliitis and is at least equal to CT with lower irradiation.
Read the detailed description
Consecutive patients referred to CT for exploration of sacrollitis will be included and investigated with standard radiography, CT and tomosynthesis of SI joints.
Imaging examinations will be performed at day of enrollment as follow : X-ray and CT as standard management and tomosynthesis as additional evaluation. CT will be considered as the reference standard Sacroiliitis will be assessed in a centralized, blind and randomized retrospective reading of all imaging modalities by two independent radiologists.
Diagnostic performances and radiation doses of tomosynthesis will be compared to those of standard CT and X-ray examinations.
- Conditions
- Sacroiliitis
- Being tested
- Tomosynthesis of SI joints
- Keywords
- Sacroiliitis, SI joint, tomosynthesis, CT, Xray
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomosynthesis of SI jointsDevice
All patients will undergo additional tomosynthesis performed per study protocol along with Xray and CT performed as part of standard imaging evaluation of sacroillitis.
Tomosynthesis of SI joints will be performed on a digital Tomosynthesis system (PLATINUM dRF v2 DMS/APELEM), with a single acquisition followed by coronal image reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis | Experimental | Tomosynthesis of SI joints Receives: Device: Tomosynthesis of SI joints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of bone erosions and other structural lesions of SI joints
sacroiliitis will be assessed independently for each imaging modality according to the modified New York criteria
Measured: 1 day of enrollment
Secondary outcomes (2)
radiation dose
Radiation dose will be measured for each imaging evaluation and calculated as the effective dose in millisievert (mSv).
Measured: 1 day of enrollment
inter reader agreement for the evaluation of sacroiliitis at tomosynthesis
Inter reader agreement will be measured at retrospective evaluation.
Measured: at the end of patients enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start4 Oct 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroiliitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- DMS Apelem, Thales, Digisens, Medecom, BPIfrance, European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Catherine Cyteval, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689881
- Sponsor's protocol ID
- RECHMPL18_0328
- Acronym
- TOMOS SI
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Tomosynthesis for Detection of Sacro-iliitis: a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT03689881
- Acronym / sponsor ID
- TOMOS SI / RECHMPL18_0328
- Conditions
- Sacroiliitis
- Keywords
- Sacroiliitis, SI joint, tomosynthesis, CT, Xray
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- DMS Apelem, Thales, Digisens, Medecom, BPIfrance, European Regional Development Fund
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spondyloarthropathies (SpAs) are chronic inflammatory diseases encompassing ankylosing spondylitis, psoriatic arthritis, reactive arthritis, enteropathic arthropathy, and undifferentiated SpA.
In 2001, the estimated prevalence of SpA was 1.5% worldwide. Sacroiliitis is a condition caused by inflammation within the sacroiliac joint. It is the most frequent damage of SpA depicted at imaging evaluation.
Conventional radiography (X-ray) is usually used to depict the structural changes associated with sacroiliitis.
However further evaluation often requires additionnal computed tomography (CT).
Tomosynthesis is an Xray-based imaging technology which allows reconstruction of multiple section images from a set of projection images acquired as the x-ray tube moves along a prescribed path. The advantagee of tomosynthesis is the significant reduction of radiation dose exposure compared to CT Tomosynthesis is currently used in the field of breast imaging and pneumology. Very few studies have examined the value of tomosynthesis for osteoarticular imaging.
The study aims at evaluating the diagnostic performances of tomosynthesis as compared to standard X-ray and CT, in patients with a clinical suspicion of sacroiliitis.
the investigators hypothesize that tomosynthesis is superior to conventional radiography for detection of sacroiliitis and is at least equal to CT with lower irradiation.
Detailed description
Consecutive patients referred to CT for exploration of sacrollitis will be included and investigated with standard radiography, CT and tomosynthesis of SI joints.
Imaging examinations will be performed at day of enrollment as follow : X-ray and CT as standard management and tomosynthesis as additional evaluation. CT will be considered as the reference standard Sacroiliitis will be assessed in a centralized, blind and randomized retrospective reading of all imaging modalities by two independent radiologists.
Diagnostic performances and radiation doses of tomosynthesis will be compared to those of standard CT and X-ray examinations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis | Experimental | Device: Tomosynthesis of SI jointsTomosynthesis of SI joints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 and over referred for suspected sacroiliitis.
- Patients who have entered into their participation agreement by signing the informed consent form.
- Patient affiliated to a social security scheme or beneficiary.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Vulnerable people according.
- Major people placed under guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomosynthesis of SI jointsAll patients will undergo additional tomosynthesis performed per study protocol along with Xray and CT performed as part of standard imaging evaluation of sacroillitis. Tomosynthesis of SI joints will be performed on a digital Tomosynthesis system (PLATINUM dRF v2 DMS/APELEM), with a single acquisition followed by coronal image reconstruction. | Device | Tomosynthesis |
Primary outcome
Presence of bone erosions and other structural lesions of SI joints
Time frame: 1 day of enrollment
sacroiliitis will be assessed independently for each imaging modality according to the modified New York criteria
2 secondary outcomes
radiation dose
Time frame: 1 day of enrollment
inter reader agreement for the evaluation of sacroiliitis at tomosynthesis
Time frame: at the end of patients enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Cyteval, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomosynthesis of SI joints in people with Sacroiliitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Cyteval, MD, PhD (+ 33 4 67 33 81 78, c-cyteval@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of bone erosions and other structural lesions of SI joints (time frame: 1 day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.