Lung CancernpUBDNCT03305978
Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.
A study testing Ultra low dose chest CT and Low dose chest CT in people with Lung Cancer and Smoking, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Smoking, Radiation Exposure
- What is being tested?
- Ultra low dose chest CT and Low dose chest CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2017to 10 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for non enhanced chest CT for following indications :
- lung nodule search or control
- nodular abnormality on chest X ray
- statement of COPD or emphysema
- asbestos exposure
- nodule localization before radio frequency ablation
Show all 10Show fewer
- assessment of disease extent of an extra thoracic cancer (in case of iodinated intravenous contrast agent contraindication)
- statement before extrathoracic transplantation (in case of iodinated intravenous contrast agent contraindication)
- Affiliated with the french social security
- Who signed consent
Who cannot join
- Inability to lie down and still during the examination
- Inability to hold breath more than 5 seconds
- Pneumonia in the last 3 months
- Body mass index more than 35kg/m²
- exclusion period of another interventionnal study
- referred for articles L1121-5 to L1121-8 of french public health code
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Pulmonary Nodules: Comparison of Ultra-low-dose Chest CT (Approaching a Two Views Chest X-ray Radiation) and Standard Low Dose CT. A Monocentric, Prospective, Non-randomized, Comparative, Open-label Study With Blind Reading of the Judgment Criteria.
Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule characterization and smoking associated findings (emphysema, bronchial abnormalities and coronary calcifications).
Read the detailed description
An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose delivered with the two acquisitions is still lower than the french diagnostic reference level. Standard CT is interpreted and a report is sent to the referent physician as usual. Then the two acquisitions are read over time by two independent radiologists, blinded over judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating than a standard low dose CT, as a sensitive tool to detect lung nodules.
- Conditions
- Lung Cancer, Smoking, Radiation Exposure
- Being tested
- Ultra low dose chest CT, Low dose chest CT
- Keywords
- Ultra low dose chest CT, lung cancer screening
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra low dose chest CTDevice
Also called Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V
An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.
Low dose chest CTDevice
Also called Revolution CT (GE Healthcare)
standard diagnostic low dose chest CT
| Study group | Role | What they receive |
|---|---|---|
| Ultra low dose chest CT | Experimental | Not described Receives: Device: Ultra low dose chest CT |
| Low dose chest CT | Active comparator | Not described Receives: Device: Low dose chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultra low dose CT lung nodule detection sensibility
Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
Measured: 22 months
Secondary outcomes (7)
Ultra low dose CT diagnostic performances of lung nodule detection
true positives, false positives, true negatives, false negatives, positive predictive value, negative predictive value, specificity, of ≥4mm lung nodules detection within ultra low dose chest CT versus standard low dose chest CT
Measured: 22 months
Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT
comparison of size, density, type (true nodule or intrapulmonary ganglion) of ≥4mm lung nodule between ultra low dose and standard low dose chest CT
Measured: 22 months
Ultra low dose CT inter-observer reproducibility
inter observer reproducibility for size, density and type of ≥4mm lung nodule detected in ultra low dose CT
Measured: 22 months
Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT
analysis of subjects characteristics (age, gender, body mass index), ≥4mm nodule location, and ≥4 mm nodule size on detection between ultra low dose and standard low dose chest CT
Measured: 22 months
Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT
comparison of emphysema detection, type (centrilobular, paraseptal, panlobular, bullous) and distribution between ultra low dose and standard low dose chest CT
Measured: 22 months
Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT
Comparison of Weston scores between ultra low dose and standard low dose chest CT
Measured: 22 months
Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT
comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start26 Sep 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Sequential
- Model description
- Major Patient Addressed for Thoracic CT without Injection of Contrast
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Ferretti, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305978
- Sponsor's protocol ID
- 38RC17.132
- Acronym
- npUBD
- Status last verified
- Aug 2019
- First submitted
- 26 Sep 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ludwig M, Chipon E, Cohen J, Reymond E, Medici M, Cole A, Moreau Gaudry A, Ferretti G. Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V. BMJ Open. 2019 Aug 15;9(8):e025661. doi: 10.1136/bmjopen-2018-025661.
PubMed 31420379
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pulmonary Nodules: Comparison of Ultra-low-dose Chest CT (Approaching a Two Views Chest X-ray Radiation) and Standard Low Dose CT. A Monocentric, Prospective, Non-randomized, Comparative, Open-label Study With Blind Reading of the Judgment Criteria.
- ClinicalTrials.gov ID
- NCT03305978
- Acronym / sponsor ID
- npUBD / 38RC17.132
- Conditions
- Lung Cancer, Smoking, Radiation Exposure
- Keywords
- Ultra low dose chest CT, lung cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 10 Oct 2017 (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.
Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule characterization and smoking associated findings (emphysema, bronchial abnormalities and coronary calcifications).
Detailed description
An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose delivered with the two acquisitions is still lower than the french diagnostic reference level. Standard CT is interpreted and a report is sent to the referent physician as usual. Then the two acquisitions are read over time by two independent radiologists, blinded over judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating than a standard low dose CT, as a sensitive tool to detect lung nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Major Patient Addressed for Thoracic CT without Injection of Contrast
| Arm | Type | Receives |
|---|---|---|
| Ultra low dose chest CT | Experimental | Device: Ultra low dose chest CT |
| Low dose chest CT | Active comparator | Device: Low dose chest CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients referred for non enhanced chest CT for following indications :
- Affiliated with the french social security
- Who signed consent
Key exclusion criteria (7 listed)
- Inability to lie down and still during the examination
- Inability to hold breath more than 5 seconds
- Pneumonia in the last 3 months
- Body mass index more than 35kg/m²
- exclusion period of another interventionnal study
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 |
|---|---|---|
| Ultra low dose chest CTAlso: Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR VAn additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT. | Device | Ultra low dose chest CT |
| Low dose chest CTAlso: Revolution CT (GE Healthcare)standard diagnostic low dose chest CT | Device | Low dose chest CT |
Primary outcome
Ultra low dose CT lung nodule detection sensibility
Time frame: 22 months
Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
7 secondary outcomes
Ultra low dose CT diagnostic performances of lung nodule detection
Time frame: 22 months
Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT
Time frame: 22 months
Ultra low dose CT inter-observer reproducibility
Time frame: 22 months
Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT
Time frame: 22 months
Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT
Time frame: 22 months
Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT
Time frame: 22 months
Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT
Time frame: 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Derived from this study: PubMed 31420379Ludwig M, Chipon E, Cohen J, Reymond E, Medici M, Cole A, Moreau Gaudry A, Ferretti G. Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V. BMJ Open. 2019 Aug 15;9(8):e025661. doi: 10.1136/bmjopen-2018-025661.
- 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.
Gilbert Ferretti, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra low dose chest CT and Low dose chest CT in people with Lung Cancer and Smoking, run by University Hospital, Grenoble at 1 site in France.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 21 Aug 2019. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultra low dose CT lung nodule detection sensibility (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03305978, which also lists 1 linked publication.
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 21 Aug 2019.