Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques

Study Overview
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Brief Summary
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To compare 2 different image creation/processing techniques during a standard CT scan in order to see problems in the liver and learn which method provides better image quality. The techniques use new artificial intelligence software to decrease image noise, which helps the radiologist to evaluate.

Detailed Description
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Primary Objective: To evaluate whether post-processing software Adaptive Statistical Iterative Reconstruction (ASIR), ASIR-V, Veo 3.0 (GE version of Model-based Iterative Reconstruction (MBIR), and Deep Learning Image Reconstruction (DLIR) is able to preserve lesion detection in the liver and other measures of image quality at reduced radiation doses for computed tomography (CT). Secondary Objectives: Assessment of whether post-processing software enhances lesion detection in the liver and other measures of image quality at standard and reduced radiation doses. Assessment of whether DLIR and GSI DLIR reconstructions perform differently, both in terms of accuracy and image quality metrics such as noise reduction.

Official Title
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Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques

Conditions
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Diseases of Liver, Colon Carcinoma, Colorectal Carcinoma, Liver Metastases

Intervention / Treatment
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* Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction
* Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction
* Diagnostic Test: Deep Learning Image Reconstruction (DLIR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be >/= 18 years of age and </=90 years of age Men and non-pregnant women Pathology proven diagnosis of colon or colorectal carcinoma Liver metastases on most recent CT examination Standard of care CT abdomen examination planned WITH IV contrast Exclusion Criteria: Patients cannot give informed consent Patients cannot undergo CT examination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computed Tomography Scan - 50% Dose Reduction<br>Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction. | Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction<br>* Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.<br>* Other names: CT scan;|
| Experimental: Computed tomography Scan - 70% Dose Reduction<br>Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction. | Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction<br>* Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.<br>* Other names: CT scan;|
| Experimental: Deep Learning Image Reconstruction (DLIR)<br>DLIR is available in both single (SE) and dual/multi energy (DE) CT scanning modes. DLIR SECT and DLIR DECT reconstructions have yet to be compared. | Diagnostic Test: Deep Learning Image Reconstruction (DLIR)<br>* Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastasis Detection Accuracy | Primary endpoint is metastasis detection accuracy status of each patient, where the standard of care scan reviewed by ''truth readers'' (independent to the blinded radiologists) serve as the gold standard. If any lesion of a patient is diagnosed as metastasis by truth readers or blinded readers' consensus, that patient will be considered true positive and diagnosis positive, respectively. The expected accuracy of standard CT is 95%, and a low dose CT detection be considered non-inferior if its accuracy is 85% or higher. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diseases of liver, Colon carcinoma, Colorectal carcinoma, Liver metastases, Computed tomography, CT, Reduced radiation doses, Deep Learning Image Reconstructions, DLIR