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?

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.

Study Overview

• Status: Terminated
• Conditions: Lung Disease; Wrist Fracture
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich - Diagnostic Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Inferiority CT	Value of Tomosynthesis-image information compared to CT	when scheduled for x-ray - 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superiority to x-ray	Value of Tomosynthesis-image information compared to x-ray	when scheduled for x-ray - 52 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Thoams Frauenfelder, MD, University Hospital Zurich, Radiology

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: CT; Tomosynthesis; monitoring; osteosynthetic implant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: SNCTP000001072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO