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NCT Number: NCT06579547

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)

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.

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Key information

Conditions

Joint Diseases Arthritis Joint Inflammation Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Location status: Recruiting

Location contact

Carina Obermüller, Dr. med.

CONTACT

[email protected]

‭0041763654453‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Total score for bone erosions

    Time frame: 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.

  2. Total score for joint space narrowing

    Time frame: 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.

  3. Visibility of cortical bone

    Time frame: one day (day of MRI and CT examination)

    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.

  4. Visibility of trabecular bone

    Time frame: one day (day of MRI and CT examination)

    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.

  5. Visibility of soft tissue calcifications

    Time frame: one day (day of MRI and CT examination)

    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.

  6. Contrast to noise ratio

    Time frame: 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.

  7. Signal to noise ratio

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carina Obermüller, Dr. med.

CONTACT

[email protected]

‭0041763654453‬

Roman Guggenberger, PD Prof. Dr. med.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Roman Guggenberger

Other

Registry information

Official study title

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

Acronym: DLZTECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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