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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02464280
Enrollment
60
Registered
2015-06-08
Start date
2016-05-31
Completion date
2020-10-31
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Disease, Wrist Fracture

Keywords

Tomosynthesis, osteosynthetic implant, CT, monitoring

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.

Interventions

OTHERTomosythesis 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.

OTHERCT 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.

OTHERconventional 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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Non-Inferiority CTwhen scheduled for x-ray - 52 weeksValue of Tomosynthesis-image information compared to CT

Secondary

MeasureTime frameDescription
Superiority to x-raywhen scheduled for x-ray - 52 weeksValue of Tomosynthesis-image information compared to x-ray

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026