Joint DiseasesDLZTECTNCT06579547
Evaluating Replacement of Standard-of-care Low Dose Computer Tomography (CT) Scans With Radiation-free Bone Imaging by Deep-learning Augmented Zero Echo Time (DL-ZTE) Magnetic Resonance Tomography (MRT)
A study testing Low Dose Computer Tomography in people with Joint Diseases and Joint Inflammation, run by Roman Guggenberger at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to determine how effectively bone structures of the human skeleton can be visualized using Deep Learning (DL) augmented Magnetic Resonance Imaging (MRI) in individuals with inflammatory and degenerative joint changes, compared to Computed Tomography (CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Diseases, Joint Inflammation
- What is being tested?
- Low Dose Computer Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2024to Jul 2026
- 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
- Referral for a clinically indicated MRI examination of the musculoskeletal system to assess inflammatory and degenerative joint changes.
- Willingness to sign the informed consent form.
- No contraindications for a CT examination (e.g., claustrophobia).
Who cannot join
- No signed informed consent form.
- Patients under 18 years of age.
- Pregnant women.
- The calculated effective dose of the CT examination exceeds 5 mSv.
Trial locations and contacts
1 site in 1 country.
Roman Guggenberger, PD Prof. Dr. med. contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Carina Obermüller, Dr. med., 0041763654453, carina.obermueller@usz.ch
About this study
Official title: Single-center Prospective Comparison of Diagnostic Performance of Deep-learning Agumented UTE/ZTE MRI Sequences and Standard-of-care Low Dose CT for Rheumatologic Patients With Musculoskeletal Disease
The goal of this clinical trial is to determine how effectively bone structures of the human skeleton can be visualized using Deep Learning (DL) augmented Magnetic Resonance Imaging (MRI) in individuals with inflammatory and degenerative joint changes, compared to Computed Tomography (CT). MRI is a technique that operates without the use of X-rays. The main question it aims to answer is:
- Can DL MRI accurately depict bone structures as well as CT?
- Can DL MRI be used as an alternative to CT to avoid exposure to X-rays in the future?
Read more
Researchers will compare DL MRI scans to CT scans to see if DL MRI can effectively replace CT in visualizing bone structures without the use of radiation.
Participants will:
- Undergo MRI scans of their skeletal system that will then be processed using DL.
- Undergo CT scans of the same body region for comparison purposes.
- Conditions
- Joint Diseases, Joint Inflammation
- Being tested
- Low Dose Computer Tomography
- Medical subject headings
- Joint Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Computer TomographyRadiation
Participants will undergo MRI scans of their skeletal system, followed by the Intervention of a Low Dose CT scan of the same body region for comparison purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score for bone erosions
Each bone is scored separately. The scale is 0-10, based on the proportion of eroded bone compared to the "assessed bone volume," judged on all available images: 0: no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. For long bones, the "assessed bone volume" is from the articular surface (or its best estimated position if absent) to a depth of 1 cm, while in carpal/tarsal bones it is the whole bone.
Example of bone list for hands: carpal bones, distal radius, distal ulna, metacarpal bases; metacarpophalangeal, MCP, joints: metacarpal head, phalangeal base; maximum points: 230.
A higher score means more bone erosions.
Note: The total score will vary according to body area imaged, this will be taken into account in the final analysis.
Measured: one day (day of MRI and CT examination)
Total score for joint space narrowing
0: no narrowing, 1: focal or mild (< 33%), 2: moderate (34-66%), 3: moderate to severe (67-99%), 4: ankylosis
A higher score means more joint space narrowing.
Note: The total score will vary according to body area imaged, this will be taken into account in the final analysis.
Measured: one day (day of MRI and CT examination)
Visibility of cortical bone
Scale from 1 to 4
- hardly visible
- diagnostic with some artifact
- diagnostic with little artifact
- very good depiction
A higher score means better image quality.
Measured: one day (day of MRI and CT examination)
Visibility of trabecular bone
Scale from 1 to 4
- hardly visible
- diagnostic with some artifact
- diagnostic with little artifact
- very good depiction
A higher score means better image quality.
Measured: one day (day of MRI and CT examination)
Visibility of soft tissue calcifications
Scale from 1 to 4
- hardly visible
- diagnostic with some artifact
- diagnostic with little artifact
- very good depiction
A higher score means better image quality.
Measured: one day (day of MRI and CT examination)
Contrast to noise ratio
Average signal of erosion minus average signal of adjacent healthy bone, divided by the average background signal
A higher score means better contrast of erosions when standardized for healthy adjacent bone and against the background.
Measured: one day (day of MRI and CT examination)
Signal to noise ratio
Average signal of erosion divided by the average background signal
A higher score means better contrast of erosions against the background.
Measured: one day (day of MRI and CT examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roman Guggenberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roman Guggenberger, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579547
- Sponsor's protocol ID
- DLZTECT
- Acronym
- DLZTECT
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 30 Aug 2024
- 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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Comparison of Diagnostic Performance of Deep-learning Agumented UTE/ZTE MRI Sequences and Standard-of-care Low Dose CT for Rheumatologic Patients With Musculoskeletal Disease
- ClinicalTrials.gov ID
- NCT06579547
- Acronym / sponsor ID
- DLZTECT / DLZTECT
- Conditions
- Joint Diseases, Joint Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roman GuggenbergerUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
The goal of this clinical trial is to determine how effectively bone structures of the human skeleton can be visualized using Deep Learning (DL) augmented Magnetic Resonance Imaging (MRI) in individuals with inflammatory and degenerative joint changes, compared to Computed Tomography (CT). MRI is a technique that operates without the use of X-rays. The main question it aims to answer is:
- Can DL MRI accurately depict bone structures as well as CT?
- Can DL MRI be used as an alternative to CT to avoid exposure to X-rays in the future?
Researchers will compare DL MRI scans to CT scans to see if DL MRI can effectively replace CT in visualizing bone structures without the use of radiation.
Participants will:
- Undergo MRI scans of their skeletal system that will then be processed using DL.
- Undergo CT scans of the same body region for comparison purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referral for a clinically indicated MRI examination of the musculoskeletal system to assess inflammatory and degenerative joint changes.
- Willingness to sign the informed consent form.
- No contraindications for a CT examination (e.g., claustrophobia).
Key exclusion criteria (4 listed)
- No signed informed consent form.
- Patients under 18 years of age.
- Pregnant women.
- The calculated effective dose of the CT examination exceeds 5 mSv.
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 |
|---|---|---|
| Low Dose Computer TomographyParticipants will undergo MRI scans of their skeletal system, followed by the Intervention of a Low Dose CT scan of the same body region for comparison purposes. | Radiation | – |
Primary outcome
Total score for bone erosions
Time frame: one day (day of MRI and CT examination)
Each bone is scored separately. The scale is 0-10, based on the proportion of eroded bone compared to the "assessed bone volume," judged on all available images: 0: no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. For long bones, the "assessed bone volume" is from the articular surface (or its best estimated position if absent) to a depth of 1 cm, while in carpal/tarsal bones it is the whole bone. Example of bone list for hands: carpal bones, distal radius, distal ulna, metacarpal bases; metacarpophalangeal, MCP, joints: metacarpal head, phalangeal base; maximum points: 230. A higher score means more bone erosions. Note: The total score will vary according to body area imaged, this will be taken into account in the final analysis.
Total score for joint space narrowing
Time frame: one day (day of MRI and CT examination)
0: no narrowing, 1: focal or mild (< 33%), 2: moderate (34-66%), 3: moderate to severe (67-99%), 4: ankylosis A higher score means more joint space narrowing. Note: The total score will vary according to body area imaged, this will be taken into account in the final analysis.
Visibility of cortical bone
Time frame: one day (day of MRI and CT examination)
Scale from 1 to 4 1. hardly visible 2. diagnostic with some artifact 3. diagnostic with little artifact 4. very good depiction A higher score means better image quality.
Visibility of trabecular bone
Time frame: one day (day of MRI and CT examination)
Scale from 1 to 4 1. hardly visible 2. diagnostic with some artifact 3. diagnostic with little artifact 4. very good depiction A higher score means better image quality.
Visibility of soft tissue calcifications
Time frame: one day (day of MRI and CT examination)
Scale from 1 to 4 1. hardly visible 2. diagnostic with some artifact 3. diagnostic with little artifact 4. very good depiction A higher score means better image quality.
Contrast to noise ratio
Time frame: one day (day of MRI and CT examination)
Average signal of erosion minus average signal of adjacent healthy bone, divided by the average background signal A higher score means better contrast of erosions when standardized for healthy adjacent bone and against the background.
Signal to noise ratio
Time frame: one day (day of MRI and CT examination)
Average signal of erosion divided by the average background signal A higher score means better contrast of erosions against the background.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- 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.
Roman Guggenberger, PD Prof. Dr. med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Computer Tomography in people with Joint Diseases and Joint Inflammation, run by Roman Guggenberger at 1 site in Switzerland.
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 4 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 30 Aug 2024. 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 Switzerland. 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 Carina Obermüller, Dr. med. (0041763654453, carina.obermueller@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score for bone erosions (time frame: one day (day of MRI and CT examination)). The study lists 7 primary outcomes in all. 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 30 Aug 2024.