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NCT02464280 Clinical Trial

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

Lung Disease Clinical Trial

Official title:
Validation of Tomosynthesis for Indications for Clinical Questions Concerning Pathologies of the Chest and Skeletal Structures: When Can CT Been Omitted?

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02464280
Other study ID # SNCTP000001072
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 2016
Est. completion date October 2020

Study information
Verified date November 2020
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients scheduled for evaluation of lung-changes - Patients scheduled for evaluation of the wrist after fracture or surgery Exclusion Criteria: - general contraindications for x-Ray - general contraindications for CT - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Tomosythesis scan of the lung or the wrist
All study participants will undergo Tomosynthesis imaging of the lung or the wrist. The radiation dose of each method will be recorded.
• CT scan of the lung or the wrist
All study participants will undergo CT imaging of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.
• conventional X-ray of the lung or the wrist
All study participants will undergo conventional X-ray of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.

Locations
Country Name City State
Switzerland University Hospital Zurich - Diagnostic Radiology Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Non-Inferiority CT Value of Tomosynthesis-image information compared to CT when scheduled for x-ray - 52 weeks
Secondary Superiority to x-ray Value of Tomosynthesis-image information compared to x-ray when scheduled for x-ray - 52 weeks
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