Multiple Pulmonary NodulesRADFLNCT02468609
Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT
A study testing Ultralow-Dose-CT in people with Multiple Pulmonary Nodules and Pulmonary Emphysema, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Pulmonary Nodules, Pulmonary Emphysema
- What is being tested?
- Ultralow-Dose-CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned normal dose-CT by clinical indication at our institution
- obtained informed consent
Who cannot join
- planned lowdose-CT by clinical indication at institution
- no informed consent obtained
- age < 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Klinik für Radiologie und Nuklearmedizin
Sankt Gallen, 9007
About this study
To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.
- Conditions
- Multiple Pulmonary Nodules, Pulmonary Emphysema
- Being tested
- Ultralow-Dose-CT
- Medical subject headings
- Multiple Pulmonary Nodules, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultralow-Dose-CTRadiation
Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT
| Study group | Role | What they receive |
|---|---|---|
| Ultralow-Dose-CT | Other | Additional Ultralow-Dose-CT of the chest Receives: Radiation: Ultralow-Dose-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT
Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test
Measured: Participants CT-scan will be read out on an average date of 6 weeks after the scan
Secondary outcomes (2)
Patients BMI (Body mass index)
Measured: Measures assessed at time of read-out on an average date of 6 weeks after the scan
Patients Nodule size (mm)
Measured: Measures assessed at time of read-out on an average date of 6 weeks after the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary NodulesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Messerli, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468609
- Sponsor's protocol ID
- EKSG 15/007
- Acronym
- RADFL
- Status last verified
- Jan 2016
- First submitted
- 30 Jan 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT
- ClinicalTrials.gov ID
- NCT02468609
- Acronym / sponsor ID
- RADFL / EKSG 15/007
- Conditions
- Multiple Pulmonary Nodules, Pulmonary Emphysema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 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.
To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultralow-Dose-CT | Other | Radiation: Ultralow-Dose-CTAdditional Ultralow-Dose-CT of the chest |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned normal dose-CT by clinical indication at our institution
- obtained informed consent
Key exclusion criteria (4 listed)
- planned lowdose-CT by clinical indication at institution
- no informed consent obtained
- age < 18 years
- 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 |
|---|---|---|
| Ultralow-Dose-CTPatients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT | Radiation | Ultralow-Dose-CT |
Primary outcome
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT
Time frame: Participants CT-scan will be read out on an average date of 6 weeks after the scan
Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test
2 secondary outcomes
Patients BMI (Body mass index)
Time frame: Measures assessed at time of read-out on an average date of 6 weeks after the scan
Patients Nodule size (mm)
Time frame: Measures assessed at time of read-out on an average date of 6 weeks after the scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultralow-Dose-CT in people with Multiple Pulmonary Nodules and Pulmonary Emphysema, run by Cantonal Hospital of St. Gallen 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 4 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: status not confirmed, as of the sponsor's last update on 27 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Messerli, MD (0041 71 494 66 66, Michael.Messerli@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT (time frame: Participants CT-scan will be read out on an average date of 6 weeks after the scan). 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 27 Jan 2016.