Pulmonary Nodule, MultipleNCT03159377
Ultra-Low Dose CT Denoising for Lung Nodule Detection
An observational study of Pulmonary Nodule, Multiple, run by Sheba Medical Center at 1 site in Israel.
Trial summary
We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult patients undergoing a clinically indicated chest CT. Using a recently developed computationally efficient algorithm for the denoising of ULDCT scans after image reconstruction, we will compare the sensitivity, specificity and… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pulmonary Nodule, Multiple
- What is being tested?
- Ultra low dose chest CT
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jul 2017to 6 Jul 2021
- 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 to 110 years
- All sexes
- Adult, Older adult
Study population: Any adult patient scheduled for a chest CT, in-patient or outpatient, in our institution
Who may be able to join
- Any adult patient scheduled for a chest CT, in-patient or outpatient
Who cannot join
- Children
Trial locations and contacts
1 site in 1 country.
About this study
We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult patients undergoing a clinically indicated chest CT. Using a recently developed computationally efficient algorithm for the denoising of ULDCT scans after image reconstruction, we will compare the sensitivity, specificity and accuracy of lesion detection with the ULDCT as compared to the regular CT scan.
Read the detailed description
Patient cohort: Two hundred patients will be recruited for this study. Patients will be comprised of two groups: an inpatient group of patients from the Internal Medicine Department E for which a chest CT is ordered during their hospitalization; and ambulatory patients arriving for an ambulatory chest CT in the early afternoon. The treating clinician ordering the chest CT for the patients from Internal Medicine E will consent the inpatients while a chest radiologist from the Radiology Department will consent the outpatients arriving in the early afternoon for a chest CT study. For inclusion in the study, patients will be adults, older than 18 years old with the ability to follow orders and hold their breath for 8 seconds as determined by the physician at time of study consent.
Imaging method: All patients consented for this study will be imaged on a dedicated scanner for the study, Revolution (GE, Milwaukee, WI). Immediately following the patient's diagnostic chest CT scan, an ultra low dose chest CT scan will be obtained. The routine CT scans of the patients consented for this study will be performed using our routine protocol on the GE Revolution which typically delivers at our institution an average effective dose of 2.9mSv (range 0.95-3.01mSv) while our other Philips routine chest CT scan delivers an average effective dose of 10.5mSv (range 10.29-12.95mSv). With the addition of the ultra low dose technique, which delivers a radiation dose of a range of 0.5-1 mSv (calculated from a pilot study we obtained on pigs), patients are expected to get an total radiation dose for both scans together of about 4 mSv which is less than 10.5mSv (the normal dose for the Phillips CT machine at our institution). Just as a comparison, a meticulous study looking at multiple institutions showed that the average effective dose from a routine chest CT is 7mSv, range 4-18mSv and for a chest CT with pulmonary embolism protocol an average effective dose of 15mSv with a range of 13-40mSv .
Image evaluation: The diagnostic chest CT scan will be sent to the PACS as usual and interpreted immediately, during the same day, as per normal inpatient clinical operations protocol at our institution. The ultra low dose CT scan will be automatically sent to the computational imaging lab processing station, which will denoise the image. After denoising the images will be automatically forwarded to the PACS under the same accession number of the routine chest CT scan. Comparison of the ultra low dose denoised images to the routine chest CT images will be performed by an experienced chest radiologist at a later date, at least one week after date of acquisition to prevent any memorability of the original image. Radiologists' memory of findings has been shown to be poor, even when viewed immediately but slightly worse when time passes [Evans]. The radiologist will document the presence of nodules, consolidation, ground glass opacities, emphysema, fibrosis with abnormalities marked on the images in the PACS. Following completion of the table, the routine chest CT scan will be used as the gold standard for the presence of the imaging findings. The documented ultra low dose CT findings will be compared to the images from the routine chest CT scans. Each finding documented will be individually documented as a true finding if also seen on the routine chest CT scan or false finding if not present on the routine chest CT scan. Additional findings only seen on the routine chest CT scan will be documented as missed findings.
- Conditions
- Pulmonary Nodule, Multiple
- Being tested
- Ultra low dose chest CT
- Keywords
- pulmonary nodule, CT, low dose
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra low dose chest CTDevice
Performing an ultra low dose chest CT (ULDCT) in addition to a clinically indicated chest CT and assessing nodule detection with a recently developed denoising algorithm
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for a chest CT | Inpatients or outpatients scheduled for a chest CT in our medical center Receives: Device: Ultra low dose chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a pulmonary nodule
Comparison of sensitivity, specificity and accuracy in identifying a pulmonary nodule when comparing denoised ULDCT to a regular CT.
Measured: Patient collection in two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start4 Jul 2017
- Primary completion31 Jan 2018
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, MultipleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Edith Marom, Sheba Medical Center
- Investigators
- Edith M Marom, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159377
- Sponsor's protocol ID
- SHEBA - 16- 3651- EM - CTIL
- Status last verified
- Oct 2021
- First submitted
- 17 May 2017
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The only specific data of this study is low dose CT images while everything else is patient's usual care and not part of the study. Have not decided who may or may not use our low dose images.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Low Dose CT Denoising for Lung Nodule Detection
- ClinicalTrials.gov ID
- NCT03159377
- Acronym / sponsor ID
- SHEBA - 16- 3651- EM - CTIL
- Conditions
- Pulmonary Nodule, Multiple
- Keywords
- pulmonary nodule, CT, low dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 18 May 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.
We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult patients undergoing a clinically indicated chest CT. Using a recently developed computationally efficient algorithm for the denoising of ULDCT scans after image reconstruction, we will compare the sensitivity, specificity and accuracy of lesion detection with the ULDCT as compared to the regular CT scan.
Detailed description
Patient cohort: Two hundred patients will be recruited for this study. Patients will be comprised of two groups: an inpatient group of patients from the Internal Medicine Department E for which a chest CT is ordered during their hospitalization; and ambulatory patients arriving for an ambulatory chest CT in the early afternoon. The treating clinician ordering the chest CT for the patients from Internal Medicine E will consent the inpatients while a chest radiologist from the Radiology Department will consent the outpatients arriving in the early afternoon for a chest CT study. For inclusion in the study, patients will be adults, older than 18 years old with the ability to follow orders and hold their breath for 8 seconds as determined by the physician at time of study consent.
Imaging method: All patients consented for this study will be imaged on a dedicated scanner for the study, Revolution (GE, Milwaukee, WI). Immediately following the patient's diagnostic chest CT scan, an ultra low dose chest CT scan will be obtained. The routine CT scans of the patients consented for this study will be performed using our routine protocol on the GE Revolution which typically delivers at our institution an average effective dose of 2.9mSv (range 0.95-3.01mSv) while our other Philips routine chest CT scan delivers an average effective dose of 10.5mSv (range 10.29-12.95mSv). With the addition of the ultra low dose technique, which delivers a radiation dose of a range of 0.5-1 mSv (calculated from a pilot study we obtained on pigs), patients are expected to get an total radiation dose for both scans together of about 4 mSv which is less than 10.5mSv (the normal dose for the Phillips CT machine at our institution). Just as a comparison, a meticulous study looking at multiple institutions showed that the average effective dose from a routine chest CT is 7mSv, range 4-18mSv and for a chest CT with pulmonary embolism protocol an average effective dose of 15mSv with a range of 13-40mSv .
Image evaluation: The diagnostic chest CT scan will be sent to the PACS as usual and interpreted immediately, during the same day, as per normal inpatient clinical operations protocol at our institution. The ultra low dose CT scan will be automatically sent to the computational imaging lab processing station, which will denoise the image. After denoising the images will be automatically forwarded to the PACS under the same accession number of the routine chest CT scan. Comparison of the ultra low dose denoised images to the routine chest CT images will be performed by an experienced chest radiologist at a later date, at least one week after date of acquisition to prevent any memorability of the original image. Radiologists' memory of findings has been shown to be poor, even when viewed immediately but slightly worse when time passes [Evans]. The radiologist will document the presence of nodules, consolidation, ground glass opacities, emphysema, fibrosis with abnormalities marked on the images in the PACS. Following completion of the table, the routine chest CT scan will be used as the gold standard for the presence of the imaging findings. The documented ultra low dose CT findings will be compared to the images from the routine chest CT scans. Each finding documented will be individually documented as a true finding if also seen on the routine chest CT scan or false finding if not present on the routine chest CT scan. Additional findings only seen on the routine chest CT scan will be documented as missed findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for a chest CT | – | Device: Ultra low dose chest CTInpatients or outpatients scheduled for a chest CT in our medical center |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any adult patient scheduled for a chest CT, in-patient or outpatient, in our institution
Key inclusion criteria (1 listed)
- Any adult patient scheduled for a chest CT, in-patient or outpatient
Key exclusion criteria (1 listed)
- Children
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 CTPerforming an ultra low dose chest CT (ULDCT) in addition to a clinically indicated chest CT and assessing nodule detection with a recently developed denoising algorithm | Device | Patients scheduled for a chest CT |
Primary outcome
Identification of a pulmonary nodule
Time frame: Patient collection in two years
Comparison of sensitivity, specificity and accuracy in identifying a pulmonary nodule when comparing denoised ULDCT to a regular CT.
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 15 Oct 2021.
- Individual participant dataSharing planned: Undecided. The only specific data of this study is low dose CT images while everything else is patient's usual care and not part of the study. Have not decided who may or may not use our low dose images.
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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.
Edith M Marom, MD principal investigator
Sheba Medical Center
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 Pulmonary Nodule, Multiple, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 15 Oct 2021. 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 Israel. 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?
Identification of a pulmonary nodule (time frame: Patient collection in two years). 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 15 Oct 2021.