Imaging, DiagnosticUL2DLRNCT05840003
Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
A study testing Ultra-Low-Dose thoraco-abdominopelvic scan in people with Imaging, Diagnostic and Lung Diseases, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The new image reconstruction algorithm (Precise Image, Philips Healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imaging, Diagnostic, Lung Diseases, Abdomen Disease
- What is being tested?
- Ultra-Low-Dose thoraco-abdominopelvic scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2023to 15 Sep 2024
- 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
- Patient having given free and informed consent.
- Patient who has signed the consent form.
- Patient affiliated to or beneficiary of a health insurance plan.
- Patient with a BMI < 35 kg/m2
Who cannot join
- Patient participating in research involving human subjects defined as Category 1.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship or trusteeship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
- Pregnant patient.
- Patient with a BMI ≥ 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance of Image Quality Between an Ultra-Low Dose (ULD) Scanner and Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
The new image reconstruction algorithm (Precise Image, Philips Healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.
The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.
Read the detailed description
Recently a new image reconstruction algorithm based on Deep-learning has been developed (Precise Image, Philips Healthcare). Initial studies on phantoms have shown that this algorithm improves image quality and reduces patient dose compared to the iDose4 iterative reconstruction algorithm. Feasibility studies have validated the image quality for low-dose levels (LD). However, this algorithm has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.
The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.
The purpose of this study is to evaluate the concordance of the global quality of thoraco-abdominopelvic images of a ULD scan acquisition compared to a standard dose CT acquisition and measure the global agreement of the global quality of the images with a 4-point Likert scale.
The ULD acquisition will allow a significant reduction in the X-ray dose delivered to patients compared to a standard dose conventional scanner. This reduction is estimated at 70%.
- Being tested
- Ultra-Low-Dose thoraco-abdominopelvic scan
- Medical subject headings
- Disease, Lung Diseases, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-Low-Dose thoraco-abdominopelvic scanRadiation
In addition to the usual management (i.e. standard dose Computed Tomography), an Ultra-Low-Dose thoraco-abdominopelvic scan will be routinely performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan | Experimental | All adult patients (except pregnant women) presenting to the imaging department of the Institut de Cancérologie du Gard for a thoraco-abdominopelvic scan as part of an oncology follow-up will under a standard-dose can as well as an ultra-low-dose scan. Receives: Radiation: Ultra-Low-Dose thoraco-abdominopelvic scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition
A 4-point Likert scale will be used to evaluate the overall image quality to see whether it is good enough to visualize the structures of interest and possible lesions.
Overall image quality is rated as follows:
- Completely interpretable without noise, smoothing, and/or artifact,
- Completely interpretable with low artifacts and/or low level of noise or/and smoothing,
- Interpretable with moderate noise and/or smoothing and moderate artifacts,
- Uninterpretable
Measured: Day 0
Secondary outcomes (18)
Distribution of image quality with the standard dose scanner
Distribution of image quality for each of the two examinations of interest (ULD scanner and standard dose scanner) and to estimate the frequency of good quality images (level 1-2) for each of the two examinations.
- - Fully interpretable without noise, smoothing and/or artifact,
- - Fully interpretable with low artifacts and/or low noise and/or smoothing,
- - Interpretable despite moderate noise and/or smoothing and moderate artifacts,
- - Not interpretable
Measured: Day 0
Frequency of good quality images with the standard dose scanner
Distribution of image quality for each of the two examinations of interest (ULD scanner and standard dose scanner) and to estimate the frequency of good quality images (level 1-2) for each of the two examinations. Grouping of the variable into 2 classes for the estimation of the frequency of good quality (1-2) images:- 1-2 vs. 3-4
Measured: Day 0
Distribution of image quality with the Ultra-Low-Dose scanner
Distribution of image quality for each of the two examinations of interest (ULD scanner and standard dose scanner) and to estimate the frequency of good quality images (level 1-2) for each of the two examinations.
- - Fully interpretable without noise, smoothing and/or artifact,
- - Fully interpretable with low artifacts and/or low noise and/or smoothing,
- - Interpretable despite moderate noise and/or smoothing and moderate artifacts,
- - Not interpretable
Measured: Day 0
Frequency of good quality images with the Ultra-Low-Dose scanner
Distribution of image quality for each of the two examinations of interest (ULD scanner and standard dose scanner) and to estimate the frequency of good quality images (level 1-2) for each of the two examinations. Grouping of the variable into 2 classes for the estimation of the frequency of good quality (1-2) images:- 1-2 vs. 3-4
Measured: Day 0
Confidence level of each radiologist's diagnosis : Ultra-Low-Dose scan acquisition
To compare the confidence level of each radiologist's diagnosis for each of the two examinations of interest (Ultra-Low-Dose scan and standard dose scan) a subjective assessment of the each radiologist's (Junior/Senior) diagnostic confidence level will be made.
Measured: Day 0
Confidence level of each radiologist's diagnosis : Standard-Dose scan acquisition
To compare the confidence level of each radiologist's diagnosis for each of the two examinations of interest (Ultra-Low-Dose scan and standard dose scan) a subjective assessment of the each radiologist's (Junior/Senior) diagnostic confidence level will be made.
Measured: Day 0
Inter-rater agreement (Senior vs. junior radiologist) regarding the Ultra-Low-Dose scan acquisitions
Likert scales for global image quality and the level of confidence of the diagnosis will be used to assess inter-rater agreement (senior radiologist vs. junior radiologist) for each CT acquisition.
Measured: Day 0
Inter-rater agreement (Senior vs. junior radiologist) regarding the Standard-Dose scan acquisitions
Likert scales for global image quality and the level of confidence of the diagnosis will be used to assess inter-rater agreement (senior radiologist vs. junior radiologist) for each CT acquisition.
Measured: Day 0
Overall concordance of the diagnosis. Thoracic lesions seen on the Ultra-Low-Dose scan
Overall concordance of the diagnosis of thoracic, abdominal and/or pelvic lesions made from a ULD scan or from a conventional standard dose scan in these patients.
Presence of at least one thoracic, (Yes/No)
Measured: Day 0
Overall concordance of the diagnosis. Thoracic lesions seen on the Standard-Dose scan
Overall concordance of the diagnosis of thoracic, abdominal and/or pelvic lesions made from a ULD scan or from a conventional standard dose scan in these patients. Presence of at least one thoracic lesion (Yes/No)
Measured: Day 0
Overall concordance of the diagnosis. Abdominal lesions seen on the Ultra-Low-Dose scan
Overall concordance of the diagnosis of thoracic, abdominal and/or pelvic lesions made from a ULD scan or from a conventional standard dose scan in these patients. Presence of at least one abdominal lesion (Yes/No)
Measured: Day 0
Overall concordance of the diagnosis. Abdominal lesions seen on the Standard-Dose scan
Overall concordance of the diagnosis of thoracic, abdominal and/or pelvic lesions made from a ULD scan or from a conventional standard dose scan in these patients. Presence of at least one abdominal lesion (Yes/No)
Measured: Day 0
Overall concordance of the diagnosis. Pelvic lesions seen on the Ultra-Low-Dose scan
Overall concordance of the diagnosis of thoracic, abdominal and/or pelvic lesions made from a ULD scan or from a conventional standard dose scan in these patients. Presence of at least one pelvic lesion (Yes/No)
Measured: Day 0
Overall concordance of the diagnosis. Pelvic lesions seen on the Standard-Dose scan
Overall concordance of the diagnosis of thoracic, abdominal and/or pelvic lesions made from a ULD scan or from a conventional standard dose scan in these patients. Presence of at least one pelvic lesion (Yes/No)
Measured: Day 0
Overall concordance of the diagnosis. Spine lesions seen on the Ultra-Low-Dose scan
Overall concordance of the diagnosis of bone lesions of the spine and pelvis made from a ULD scan or from a standard dose CT scan in these patients. Presence of at least one bone lesion within the spine (Yes/No).
Measured: Day 0
Overall concordance of the diagnosis. Spine lesions seen on the Standard-Dose scan
Overall concordance of the diagnosis of bone lesions of the spine and pelvis made from a ULD scan or from a standard dose CT scan in these patients. Presence of at least one bone lesion within the spine (Yes/No).
Measured: Day 0
Overall concordance of the diagnosis. Pelvic bone lesions seen on the Ultra-Low-Dose scan
Overall concordance of the diagnosis of bone lesions of the spine and pelvis made from a ULD scan or from a standard dose CT scan in these patients. Presence of at least one bone lesion on the pelvis (Yes/No).
Measured: Day 0
Overall concordance of the diagnosis. Pelvic bone lesions seen on the Standard-Dose scan
Overall concordance of the diagnosis of bone lesions of the spine and pelvis made from a ULD scan or from a standard dose CT scan in these patients. Presence of at least one bone lesion on the pelvis (Yes/No).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start15 Sep 2023
- Primary completion15 Jul 2024
- Study completion15 Sep 2024
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 Imaging, DiagnosticStudies 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
- Model description
- Monocentric study of the subject as his/her own control
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien FRANDON, Prof., Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840003
- Sponsor's protocol ID
- LOCAL/2022/JG-01
- Acronym
- UL2DLR
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Oliveira F, Ghabri S, Benhalilou S, Alonso S, Dhombres E, Beregi JP, Dabli D, Frandon J, Greffier J. Ultra-low dose chest-abdomen-pelvis CT with deep-learning image reconstruction for cancer follow-up: Impact on image quality and lesion detection. Diagn Interv Imaging. 2026 Aug 11:S2211-5684(26)00139-7. doi: 10.1016/j.diii.2026.08.001. Online ahead of print.
PubMed 42580928
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of Image Quality Between an Ultra-Low Dose (ULD) Scanner and Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
- ClinicalTrials.gov ID
- NCT05840003
- Acronym / sponsor ID
- UL2DLR / LOCAL/2022/JG-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 3 May 2023 (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.
The new image reconstruction algorithm (Precise Image, Philips Healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.
The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.
Detailed description
Recently a new image reconstruction algorithm based on Deep-learning has been developed (Precise Image, Philips Healthcare). Initial studies on phantoms have shown that this algorithm improves image quality and reduces patient dose compared to the iDose4 iterative reconstruction algorithm. Feasibility studies have validated the image quality for low-dose levels (LD). However, this algorithm has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.
The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.
The purpose of this study is to evaluate the concordance of the global quality of thoraco-abdominopelvic images of a ULD scan acquisition compared to a standard dose CT acquisition and measure the global agreement of the global quality of the images with a 4-point Likert scale.
The ULD acquisition will allow a significant reduction in the X-ray dose delivered to patients compared to a standard dose conventional scanner. This reduction is estimated at 70%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric study of the subject as his/her own control
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan | Experimental | Radiation: Ultra-Low-Dose thoraco-abdominopelvic scanAll adult patients (except pregnant women) presenting to the imaging department of the Institut de Cancérologie du Gard for a thoraco-abdominopelvic scan as part of an oncology follow-up will under a standard-dose can as well as an ultra-low-dose scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient having given free and informed consent.
- Patient who has signed the consent form.
- Patient affiliated to or beneficiary of a health insurance plan.
- Patient with a BMI < 35 kg/m2
Key exclusion criteria (7 listed)
- Patient participating in research involving human subjects defined as Category 1.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship or trusteeship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
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 thoraco-abdominopelvic scanIn addition to the usual management (i.e. standard dose Computed Tomography), an Ultra-Low-Dose thoraco-abdominopelvic scan will be routinely performed. | Radiation | Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan |
Primary outcome
Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition
Time frame: Day 0
A 4-point Likert scale will be used to evaluate the overall image quality to see whether it is good enough to visualize the structures of interest and possible lesions. Overall image quality is rated as follows: 1. Completely interpretable without noise, smoothing, and/or artifact, 2. Completely interpretable with low artifacts and/or low level of noise or/and smoothing, 3. Interpretable with moderate noise and/or smoothing and moderate artifacts, 4. Uninterpretable
18 secondary outcomes
Distribution of image quality with the standard dose scanner
Time frame: Day 0
Frequency of good quality images with the standard dose scanner
Time frame: Day 0
Distribution of image quality with the Ultra-Low-Dose scanner
Time frame: Day 0
Frequency of good quality images with the Ultra-Low-Dose scanner
Time frame: Day 0
Confidence level of each radiologist's diagnosis : Ultra-Low-Dose scan acquisition
Time frame: Day 0
Confidence level of each radiologist's diagnosis : Standard-Dose scan acquisition
Time frame: Day 0
Inter-rater agreement (Senior vs. junior radiologist) regarding the Ultra-Low-Dose scan acquisitions
Time frame: Day 0
Inter-rater agreement (Senior vs. junior radiologist) regarding the Standard-Dose scan acquisitions
Time frame: Day 0
Overall concordance of the diagnosis. Thoracic lesions seen on the Ultra-Low-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Thoracic lesions seen on the Standard-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Abdominal lesions seen on the Ultra-Low-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Abdominal lesions seen on the Standard-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Pelvic lesions seen on the Ultra-Low-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Pelvic lesions seen on the Standard-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Spine lesions seen on the Ultra-Low-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Spine lesions seen on the Standard-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Pelvic bone lesions seen on the Ultra-Low-Dose scan
Time frame: Day 0
Overall concordance of the diagnosis. Pelvic bone lesions seen on the Standard-Dose scan
Time frame: Day 0
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 14 Aug 2026.
- Results publication: PubMed 42580928de Oliveira F, Ghabri S, Benhalilou S, Alonso S, Dhombres E, Beregi JP, Dabli D, Frandon J, Greffier J. Ultra-low dose chest-abdomen-pelvis CT with deep-learning image reconstruction for cancer follow-up: Impact on image quality and lesion detection. Diagn Interv Imaging. 2026 Aug 11:S2211-5684(26)00139-7. doi: 10.1016/j.diii.2026.08.001. Online ahead of print.
- 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.
Julien FRANDON, Prof. principal investigator
Nîmes University Hospital
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 thoraco-abdominopelvic scan in people with Imaging, Diagnostic and Lung Diseases, run by Centre Hospitalier Universitaire de Nīmes 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 4 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 14 Aug 2026. 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?
Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition (time frame: Day 0). 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 NCT05840003, 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 14 Aug 2026.