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Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR) (DLIRTHORAX)

Primary Purpose

Pulmonary Nodules, Multiple

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ULD CT
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Nodules, Multiple focused on measuring lung nodules, pulmonary nodules, lung cancer, radiation dose, dose reduction, low dose CT, ultra-low dose CT, DLIR, deep learning reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18 years old,
  • Patient referred for non-enhanced chest CT for lung nodule check-up or follow-up,
  • Affiliation to a social security program,
  • Ability of the subject to understand and express opposition

Exclusion Criteria:

  • Age <18 years old,
  • Person under guardianship or curatorship,
  • Pregnant woman,
  • Any contraindications to CT

Sites / Locations

  • CHU Amiens-Picardie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ultra-low dose CT

Arm Description

All the examinations are part of the routine care. Addition of the ULD CT protocol does not require injection of contrast agent and does not extend the duration of the examination.

Outcomes

Primary Outcome Measures

Diagnostic accuracy
The study aimed to investigate the diagnostic accuracy (Sensibility and Specificity) of ultra-low dose CT using DLIR reconstruction for the detection of pulmonary nodules in comparison with the low dose CT reference protocol.

Secondary Outcome Measures

Image quality
The signal-to-noise ratio or SNR is calculated on areas of interest placed manually on the image (pulmonary parenchyma, axillary fat and surrounding air). This ratio is calculated by the average signal strength in these areas, divided by the standard deviation of the signal in outdoor areas such as the surrounding air. The quality of the image is estimated by a score ranging from 0 (poor quality) to 3 (excellent quality) determined subjectively by the operator.
Pulmonary nodules volume
Difference of pulmonary nodules volume between images acquired at low dose CT and ultra-low dose CT.

Full Information

First Posted
July 15, 2020
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04482114
Brief Title
Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR)
Acronym
DLIRTHORAX
Official Title
Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.
Detailed Description
Background: Lung cancer is the leading cause of cancer deaths. Patients with pulmonary nodules often undergo multiple computed tomography (CT) examinations for diagnostic and follow-up purposes. Purpose: The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules. Abstract: Despite recent advances, lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer death worldwide because it is often diagnosed at advanced stages that are not surgically curable. Nevertheless, early detection of lung cancer allows surgical resection, offers curative treatment and the best chance of survival. There is currently no screening program in France, but individual screening can be carried out depending on risk factors. Many pulmonary nodules are discovered each year, most of which are benign. The challenge is to distinguish malignant lesions from the multitude of benign lesions. One of the most effective criteria is the doubling time of the nodules which leads to multiple follow-up examinations requiring ionizing radiation to assess the size and growth of the nodules. Great efforts are currently being made by CT manufacturers in order to reduce the radiation with equivalent diagnostic performance. Patients who were referred to our department for an unenhanced low-dose chest CT (LD CT) for pulmonary nodules check-up or follow-up, and had consented to participate in the study, will undergo an additional ultra-low dose acquisition (ULDCT, <0,25 mSv, similar to standard two-view chest X-Ray) with deep learning-based reconstruction (DLIR). The main objective of this study is to evaluate the diagnostic performance between ULD and LD CT protocols for the detection of pulmonary nodules. The impact of dose reduction will be assessed in this context. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodules, Multiple
Keywords
lung nodules, pulmonary nodules, lung cancer, radiation dose, dose reduction, low dose CT, ultra-low dose CT, DLIR, deep learning reconstruction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective transversal monocentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultra-low dose CT
Arm Type
Other
Arm Description
All the examinations are part of the routine care. Addition of the ULD CT protocol does not require injection of contrast agent and does not extend the duration of the examination.
Intervention Type
Radiation
Intervention Name(s)
ULD CT
Intervention Description
All the examinations are part of the routine care. Addition of the ULD CT protocol does not require injection of contrast agent and does not extend the duration of the examination.
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
The study aimed to investigate the diagnostic accuracy (Sensibility and Specificity) of ultra-low dose CT using DLIR reconstruction for the detection of pulmonary nodules in comparison with the low dose CT reference protocol.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Image quality
Description
The signal-to-noise ratio or SNR is calculated on areas of interest placed manually on the image (pulmonary parenchyma, axillary fat and surrounding air). This ratio is calculated by the average signal strength in these areas, divided by the standard deviation of the signal in outdoor areas such as the surrounding air. The quality of the image is estimated by a score ranging from 0 (poor quality) to 3 (excellent quality) determined subjectively by the operator.
Time Frame
Day 0
Title
Pulmonary nodules volume
Description
Difference of pulmonary nodules volume between images acquired at low dose CT and ultra-low dose CT.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old, Patient referred for non-enhanced chest CT for lung nodule check-up or follow-up, Affiliation to a social security program, Ability of the subject to understand and express opposition Exclusion Criteria: Age <18 years old, Person under guardianship or curatorship, Pregnant woman, Any contraindications to CT
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80000
Country
France

12. IPD Sharing Statement

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Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR)

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