Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT

Terminated

• Conditions: Lung Disease; Wrist Fracture
• Interventions: Other: Tomosythesis scan of the lung or the wrist; Other: CT scan of the lung or the wrist; Other: conventional X-ray of the lung or the wrist

• Registration Number: NCT02464280
• Lead Sponsor: University of Zurich

Brief Summary

The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

Detailed Description

The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

This is a prospective, single-center, non-randomised, non-blinded trial with Tomosyntheis of Patients referred to the investigators institution to assess lung alterations and bone structure. All patients will undergo chest x-ray and tomosynthesis after informed consent. In addition they will undergo an ultralow-dose CT, wich is used as standart reference. The radiation dose of each method will be recorded. After completion of these three examinations, the participation in the study is completed.

Study Timeline

• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-08
• Study Start: 2016-05
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients scheduled for evaluation of lung-changes
• Patients scheduled for evaluation of the wrist after fracture or surgery

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Exclusion Criteria

• general contraindications for x-Ray
• general contraindications for CT
• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients scheduled for wrist imaging	conventional X-ray of the lung or the wrist	Patients with wrist fracture or with osteoprotetic material in the wrist and scheduled for wrist imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan
Patients scheduled for wrist imaging	CT scan of the lung or the wrist	Patients with wrist fracture or with osteoprotetic material in the wrist and scheduled for wrist imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan
Patients scheduled for lung imaging	CT scan of the lung or the wrist	Patients with lung changes and scheduled for lung imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan
Patients scheduled for lung imaging	conventional X-ray of the lung or the wrist	Patients with lung changes and scheduled for lung imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan
Patients scheduled for wrist imaging	Tomosythesis scan of the lung or the wrist	Patients with wrist fracture or with osteoprotetic material in the wrist and scheduled for wrist imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan
Patients scheduled for lung imaging	Tomosythesis scan of the lung or the wrist	Patients with lung changes and scheduled for lung imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan

Primary Outcome Measures

Name	Time	Method
Non-Inferiority CT	when scheduled for x-ray - 52 weeks	Value of Tomosynthesis-image information compared to CT

Secondary Outcome Measures

Name	Time	Method
Superiority to x-ray	when scheduled for x-ray - 52 weeks	Value of Tomosynthesis-image information compared to x-ray

Trial Locations

Locations (1)

University Hospital Zurich - Diagnostic Radiology; 🇨🇭 Zurich, Switzerland