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)

Not Applicable

Recruiting

• Conditions: Joint Diseases; Joint Inflammation

• Registration Number: NCT06579547
• Lead Sponsor: Roman Guggenberger

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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).

Exclusion Criteria

• No signed informed consent form.
• Patients under 18 years of age.
• Pregnant women.
• The calculated effective dose of the CT examination exceeds 5 mSv.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total score for bone erosions	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland