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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoman Guggenberger

About this trial

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:

1. Can DL MRI accurately depict bone structures as well as CT? 2. 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:

1. Undergo MRI scans of their skeletal system that will then be processed using DL. 2. Undergo CT scans of the same body region for comparison purposes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Low Dose Computer Tomography

    Radiation

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
one day (day of MRI and CT examination)
2

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.

Time frame
one day (day of MRI and CT examination)
3

Visibility of cortical bone

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.

Time frame
one day (day of MRI and CT examination)
4

Visibility of trabecular bone

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.

Time frame
one day (day of MRI and CT examination)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roman Guggenberger

Lead sponsor

University of Zurich

Sponsor institution