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)

NCT06579547 | Recruiting

• 1 other identifier: DLZTECT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Can DL MRI accurately depict bone structures as well as CT?
2. 2.Can DL MRI be used as an alternative to CT to avoid exposure to X-rays in the future?
3. 3.Undergo MRI scans of their skeletal system that will then be processed using DL.
4. 4.Undergo CT scans of the same body region for comparison purposes.

Conditions

Joint Diseases; Joint Inflammation

Outcome Measures

Primary Outcomes (7)

• 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)

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Roman Guggenberger: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Joint Diseases; Arthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Central Study Contacts

Carina Obermüller, Dr. med.

CONTACT

‭0041763654453‬; carina.obermueller@usz.ch

Roman Guggenberger, PD Prof. Dr. med.

CONTACT

roman.guggenberger@ksw.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologists who perform the readout will be blinded to the reference low dose CT scan to avoid being primed for certain bony anatomy and pathology by evaluating the low dose CT first. The reference low dose CT scan will be read in a separate session.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician (Leitender Arzt)

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 30, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)