Radiation ExposureNCT06360627
Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT
A study testing Computed Tomography in people with Radiation Exposure and Lung Embolism, run by University of Zurich at 1 site in Switzerland.
Trial summary
Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure, Lung Embolism, Lung Cancer
- What is being tested?
- Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Feb 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- CT SCAN for pulmonary nodule detection/follow up
- CT SCAN for pneumonia detection/follow up
Who cannot join
- under 18
- BMI over 30
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich - Diagnostic Radiology
Zurich, 8091
Thomas Frauenfelder, PD MD, 0041442551111, thomas.frauenfelder@usz.ch
Marga Rominger, Prof MD, 0041442551111, marga.rominger@usz.ch
About this study
Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT
- Conditions
- Radiation Exposure, Lung Embolism, Lung Cancer, Pneumonia
- Being tested
- Computed Tomography
- Medical subject headings
- Pulmonary Embolism, Lung Neoplasms, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyRadiation
Computed Tomography CHEST
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Other | Standard Low Dose CT Receives: Radiation: Computed Tomography |
| Ultra Low Dose | Other | Ultra Low Dose CT Receives: Radiation: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Reduction by new scanner
mSv per exam will be recorded. This value will be put in correlation to weight (Kg), height (cm) and BMI.
Measured: through study completion, an average of 1 year
stable Image Quality in reduced dose scans
Recorded values compared in 2 populations-different contrast agents by using qualitative\&quantitative methods Qualitative:diagnostic certainty, assessability of lung structure/lesions,diagnostic reliability,
Quantitative:Assessment of tissue composition,diagnostic performance measurements Attenuation/sealing measurement (HU), signal-to-noise ratio (SNR), contrast-to-noise ratio ,size dimensions of lung structure/lesion in three dimensions in millimeters Tissue composition assessment diagnostic performance measurements (sensitivity, specificity, accuracy) diagnostic confidence: 1-4
Theses measurements will be put in correlation to the scan dose (mSv) per patient, forming two groups with matched BMI (kg/m^2)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start20 Feb 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360627
- Sponsor's protocol ID
- 2022_D0008
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT
- ClinicalTrials.gov ID
- NCT06360627
- Acronym / sponsor ID
- 2022_D0008
- Conditions
- Radiation Exposure, Lung Embolism, Lung Cancer, Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Apr 2024 (actual)
- 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.
Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Other | Radiation: Computed TomographyStandard Low Dose CT |
| Ultra Low Dose | Other | Radiation: Computed TomographyUltra Low Dose CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CT SCAN for pulmonary nodule detection/follow up
- CT SCAN for pneumonia detection/follow up
Key exclusion criteria (2 listed)
- under 18
- BMI over 30
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 |
|---|---|---|
| Computed TomographyComputed Tomography CHEST | Radiation | Low Dose, Ultra Low Dose |
Primary outcome
Dose Reduction by new scanner
Time frame: through study completion, an average of 1 year
mSv per exam will be recorded. This value will be put in correlation to weight (Kg), height (cm) and BMI.
stable Image Quality in reduced dose scans
Time frame: through study completion, an average of 1 year
Recorded values compared in 2 populations-different contrast agents by using qualitative\&quantitative methods Qualitative:diagnostic certainty, assessability of lung structure/lesions,diagnostic reliability, Quantitative:Assessment of tissue composition,diagnostic performance measurements Attenuation/sealing measurement (HU), signal-to-noise ratio (SNR), contrast-to-noise ratio ,size dimensions of lung structure/lesion in three dimensions in millimeters Tissue composition assessment diagnostic performance measurements (sensitivity, specificity, accuracy) diagnostic confidence: 1-4 Theses measurements will be put in correlation to the scan dose (mSv) per patient, forming two groups with matched BMI (kg/m^2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- 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.
University Hospital Zurich - Diagnostic Radiology
Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography in people with Radiation Exposure and Lung Embolism, 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 2 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: looking for participants now, as of the sponsor's last update on 11 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Reduction by new scanner (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 11 Apr 2024.