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 ID: NCT06579547

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-31

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.

Conditions

Joint Diseases; Joint Inflammation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

Low Dose Computer Tomography

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roman Guggenberger

OTHER

Sponsor Role: lead

Responsible Party

Roman Guggenberger

Senior Physician (Leitender Arzt)

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital Zurich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Carina Obermüller, Dr. med.

Role: CONTACT

carina.obermueller@usz.ch

‭0041763654453‬

Roman Guggenberger, PD Prof. Dr. med.

Role: CONTACT

roman.guggenberger@ksw.ch

Facility Contacts

Carina Obermüller, Dr. med.

Role: primary

carina.obermueller@usz.ch

‭0041763654453‬

Other Identifiers

DLZTECT

Identifier Type: -

Identifier Source: org_study_id