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

NCT ID: NCT02464280

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Lung Disease Wrist Fracture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Tomosythesis scan of the lung or the wrist

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Tomosythesis scan of the lung or the wrist

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thoams Frauenfelder, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Radiology

Locations

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University Hospital Zurich - Diagnostic Radiology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SNCTP000001072

Identifier Type: -

Identifier Source: org_study_id