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

NCT02464280 | Terminated

• 1 other identifier: SNCTP000001072
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease; Wrist Fracture

Keywords

Tomosynthesis; osteosynthetic implant; CT; monitoring

Outcome Measures

Primary Outcomes (1)

• Non-Inferiority CT

  Value of Tomosynthesis-image information compared to CT

  when scheduled for x-ray - 52 weeks

Secondary Outcomes (1)

• Superiority to x-ray

  when scheduled for x-ray - 52 weeks

Study Arms (2)

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; Other: CT scan of the lung or the wrist; Other: conventional X-ray of the lung or the wrist

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; Other: CT scan of the lung or the wrist; Other: conventional X-ray of the lung or the wrist

Interventions

Tomosythesis scan of the lung or the wrist OTHER

All study participants will undergo Tomosynthesis imaging of the lung or the wrist. The radiation dose of each method will be recorded.

Patients scheduled for lung imaging; Patients scheduled for wrist imaging

CT scan of the lung or the wrist 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.

Patients scheduled for lung imaging; Patients scheduled for wrist imaging

conventional X-ray of the lung or the wrist 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 lung imaging; Patients scheduled for wrist imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients scheduled for evaluation of lung-changes
• Patients scheduled for evaluation of the wrist after fracture or surgery

You may not qualify if:

• general contraindications for x-Ray
• general contraindications for CT
• pregnancy

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich - Diagnostic Radiology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Lung Diseases; Wrist Fractures

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Thoams Frauenfelder, MD

  University Hospital Zurich, Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: June 8, 2015
• Study Start: May 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)