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)
NCT Number: NCT06579547
Acronym: DLZTECT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Joint Diseases|Joint Inflammation
Interventions: RADIATION: Low Dose Computer Tomography
Sponsor: Roman Guggenberger
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2026-07
Locations: University Hospital Zurich, Zürich, 8091, Switzerland

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). 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.

Primary Outcome Measures: 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., 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., one day (day of MRI and CT examination)|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., one day (day of MRI and CT examination)|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., one day (day of MRI and CT examination)|Visibility of soft tissue calcifications, 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., 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., 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., one day (day of MRI and CT examination)