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) (DLZTECT)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Diseases; Joint Inflammation
• Intervention / Treatment: Radiation: Low Dose Computer Tomography

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carina Obermüller, Dr. med.; Phone Number: ‭0041763654453‬; Email: carina.obermueller@usz.ch
• Study Contact Backup: Name: Roman Guggenberger, PD Prof. Dr. med.; Email: roman.guggenberger@ksw.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Carina Obermüller, Dr. med.; Phone Number: ‭0041763654453‬; Email: carina.obermueller@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; hardly visible; diagnostic with some artifact; diagnostic with little artifact; 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; hardly visible; diagnostic with some artifact; diagnostic with little artifact; 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; hardly visible; diagnostic with some artifact; diagnostic with little artifact; 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)

Collaborators and Investigators

• Sponsor: Roman Guggenberger

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Arthritis; Inflammation; Joint Diseases
• Other Study ID Numbers: DLZTECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No