Lung DiseaseNCT02464280
Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT
An observational study of Lung Disease and Wrist Fracture, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease, Wrist Fracture
- What is being tested?
- Tomosythesis scan of the lung or the wrist, CT scan of the lung or the wrist and conventional X-ray of the lung or the wrist
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients scheduled for evaluation of lung-changes
- Patients scheduled for evaluation of the wrist after fracture or surgery
Who cannot join
- general contraindications for x-Ray
- general contraindications for CT
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich - Diagnostic Radiology
Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Disease, Wrist Fracture
- Being tested
- Tomosythesis scan of the lung or the wrist, CT scan of the lung or the wrist, conventional X-ray of the lung or the wrist
- Keywords
- Tomosynthesis, osteosynthetic implant, CT, monitoring
- Medical subject headings
- Lung Diseases, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomosythesis scan of the lung or the wristOther
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 wristOther
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 wristOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Inferiority CT
Value of Tomosynthesis-image information compared to CT
Measured: when scheduled for x-ray - 52 weeks
Secondary outcomes (1)
Superiority to x-ray
Value of Tomosynthesis-image information compared to x-ray
Measured: when scheduled for x-ray - 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thoams Frauenfelder, MD, Principal investigator, University Hospital Zurich, Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464280
- Sponsor's protocol ID
- SNCTP000001072
- Status last verified
- Nov 2020
- First submitted
- 25 Sep 2014
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Tomosynthesis for Indications for Clinical Questions Concerning Pathologies of the Chest and Skeletal Structures: When Can CT Been Omitted?
- ClinicalTrials.gov ID
- NCT02464280
- Acronym / sponsor ID
- SNCTP000001072
- Conditions
- Lung Disease, Wrist Fracture
- Keywords
- Tomosynthesis, osteosynthetic implant, CT, monitoring
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for lung imaging | – | 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 wristPatients with lung changes and scheduled for lung imaging will undergo: * the scheduled conventional X-ray examination * the scheduled CT scan * the tomosynthesis scan |
| Patients scheduled for wrist imaging | – | 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 wristPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients scheduled for evaluation of lung-changes
- Patients scheduled for evaluation of the wrist after fracture or surgery
Key exclusion criteria (3 listed)
- general contraindications for x-Ray
- general contraindications for CT
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomosythesis scan of the lung or the wristAll study participants will undergo Tomosynthesis imaging of the lung or the wrist. The radiation dose of each method will be recorded. | Other | Patients scheduled for lung imaging, Patients scheduled for wrist imaging |
| CT scan of the lung or the wristAll 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 | Patients scheduled for lung imaging, Patients scheduled for wrist imaging |
| conventional X-ray of the lung or the wristAll 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. | Other | Patients scheduled for lung imaging, Patients scheduled for wrist imaging |
Primary outcome
Non-Inferiority CT
Time frame: when scheduled for x-ray - 52 weeks
Value of Tomosynthesis-image information compared to CT
1 secondary outcome
Superiority to x-ray
Time frame: when scheduled for x-ray - 52 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thoams Frauenfelder, MD principal investigator
University Hospital Zurich, Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Disease and Wrist Fracture, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Inferiority CT (time frame: when scheduled for x-ray - 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.