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

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ClinicalTrials.gov Identifier: NCT02464280
Recruitment Status : Terminated
First Posted : June 8, 2015
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lung Disease Wrist Fracture 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

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Tomosynthesis for Indications for Clinical Questions Concerning Pathologies of the Chest and Skeletal Structures: When Can CT Been Omitted?
Study Start Date : May 2016
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Group/Cohort Intervention/treatment
Patients scheduled for lung imaging

Patients with lung changes and scheduled for lung imaging will undergo:

  • the scheduled conventional X-ray examination
  • the scheduled CT scan
  • the tomosynthesis scan
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.

Other: 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.

Other: 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.

Patients scheduled for wrist imaging

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
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.

Other: 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.

Other: 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.




Primary Outcome Measures :
  1. Non-Inferiority CT [ Time Frame: when scheduled for x-ray - 52 weeks ]
    Value of Tomosynthesis-image information compared to CT


Secondary Outcome Measures :
  1. Superiority to x-ray [ Time Frame: when scheduled for x-ray - 52 weeks ]
    Value of Tomosynthesis-image information compared to x-ray



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population included in this study are patients who are referred to our hospital for evaluation of lung-changes or evaluation of the wrist after fracture or surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464280


Locations
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Switzerland
University Hospital Zurich - Diagnostic Radiology
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Thoams Frauenfelder, MD University Hospital Zurich, Radiology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02464280    
Other Study ID Numbers: SNCTP000001072
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Zurich:
Tomosynthesis
osteosynthetic implant
CT
monitoring
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases