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Clinical Trials/NCT06016335
NCT06016335CompletedNot Applicable

Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region

Amsterdam UMC, location VUmc1 site in 1 country80 target enrollmentStarted: September 22, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Geometrical accuracy.

Study Overview

Brief Summary

In case of surgical procedures in the head and neck region, MRI in combination with CT of the bone is often the standard modality to visualise bony landmarks for planning, navigation and risk assessment. An important downside of a CT scan is the associated radiation exposure, especially in children. An additional downside is the sedation or general anaesthesia needed for both the MRI and CT scan session in very young children. These downsides could be removed if the CT scan can be substituted by an MRI sequence that can provide the same information as CT. This project aims to determine the feasibility of recreating CT like images of the craniofacial bones from MRI images using machine learning techniques.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients from the outpatient ENT (Ear, Nose, Throat)-clinic.
  • Aged 18 years or older.
  • Referred for CT scan of the mastoid, sinonasal complex or face.

Exclusion Criteria

  • Pregnancy.
  • Contra-indications for MRI or CT.
  • Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination.

Outcomes

Primary Outcomes

Geometrical accuracy.

Time Frame: Within one year after scans have been obtained.

Geometrical accuracy of the bone morphology by determining the mean surface distance in mm between the cortical edges on synthetic CT and on true CT.

Radiodensity accuracy.

Time Frame: Within one year after scans have been obtained.

Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast.

Visibility of landmarks.

Time Frame: Within one year after scans have been obtained.

Accuracy of the visibility of clinically relevant anatomical landmarks on the synthetic CT images compared to the corresponding true CT images in the adult population, rated by experienced physicians on a 4-point Likert scale (1 = not visible, 4 = very well visible).

Secondary Outcomes

  • Usefulness.(Within one year after scans have been obtained.)

Investigators

Sponsor
Amsterdam UMC, location VUmc
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paul Merkus

Prof. Dr.

Amsterdam UMC, location VUmc

Study Sites (1)

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