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Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans (UL2DLR)

Primary Purpose

Imaging, Diagnostic, Lung Diseases, Abdomen Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultra-Low-Dose thoraco-abdominopelvic scan
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Imaging, Diagnostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    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
    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
    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.
    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.
    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.
    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.
    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)
    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)
    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)
    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)
    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)
    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)
    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).
    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).
    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).
    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).

    Full Information

    First Posted
    April 21, 2023
    Last Updated
    April 21, 2023
    Sponsor
    Centre Hospitalier Universitaire de Nīmes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05840003
    Brief Title
    Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
    Acronym
    UL2DLR
    Official Title
    Concordance of Image Quality Between an Ultra-Low Dose (ULD) Scanner and Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nīmes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Imaging, Diagnostic, Lung Diseases, Abdomen Disease, Pelvis Disease, Bone Diseases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Monocentric study of the subject as his/her own control
    Masking
    None (Open Label)
    Masking Description
    The reading of the images from the ULD scanner acquisition will be performed blinded to the patient's clinical record, the diagnosis made by the radiologist in charge of the patient on the basis of the standard dose conventional scanner, the result of the reading of the standard dose conventional scanner study and the reading of the other evaluator.
    Allocation
    N/A
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Ultra-Low-Dose thoraco-abdominopelvic scan
    Intervention Description
    In addition to the usual management (i.e. standard dose Computed Tomography), an Ultra-Low-Dose thoraco-abdominopelvic scan will be routinely performed.
    Primary Outcome Measure Information:
    Title
    Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition
    Description
    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
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    Distribution of image quality with the standard dose scanner
    Description
    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
    Time Frame
    Day 0
    Title
    Frequency of good quality images with the standard dose scanner
    Description
    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
    Time Frame
    Day 0
    Title
    Distribution of image quality with the Ultra-Low-Dose scanner
    Description
    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
    Time Frame
    Day 0
    Title
    Frequency of good quality images with the Ultra-Low-Dose scanner
    Description
    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
    Time Frame
    Day 0
    Title
    Confidence level of each radiologist's diagnosis : Ultra-Low-Dose scan acquisition
    Description
    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.
    Time Frame
    Day 0
    Title
    Confidence level of each radiologist's diagnosis : Standard-Dose scan acquisition
    Description
    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.
    Time Frame
    Day 0
    Title
    Inter-rater agreement (Senior vs. junior radiologist) regarding the Ultra-Low-Dose scan acquisitions
    Description
    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.
    Time Frame
    Day 0
    Title
    Inter-rater agreement (Senior vs. junior radiologist) regarding the Standard-Dose scan acquisitions
    Description
    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.
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Thoracic lesions seen on the Ultra-Low-Dose scan
    Description
    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)
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Thoracic lesions seen on the Standard-Dose scan
    Description
    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)
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Abdominal lesions seen on the Ultra-Low-Dose scan
    Description
    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)
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Abdominal lesions seen on the Standard-Dose scan
    Description
    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)
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Pelvic lesions seen on the Ultra-Low-Dose scan
    Description
    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)
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Pelvic lesions seen on the Standard-Dose scan
    Description
    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)
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Spine lesions seen on the Ultra-Low-Dose scan
    Description
    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).
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Spine lesions seen on the Standard-Dose scan
    Description
    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).
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Pelvic bone lesions seen on the Ultra-Low-Dose scan
    Description
    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).
    Time Frame
    Day 0
    Title
    Overall concordance of the diagnosis. Pelvic bone lesions seen on the Standard-Dose scan
    Description
    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).
    Time Frame
    Day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joël GREFFIER, Dr.
    Phone
    +334 66 68 40 68
    Email
    Joel.GREFFIER@chu-nimes.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anissa MEGZARI
    Phone
    +33466684236
    Email
    drc@chu-nimes.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julien FRANDON, Prof.
    Organizational Affiliation
    Nîmes University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans

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