Comparison of Image Quality Between Double Low Dose Liver CT and Standard Liver CT

Study Overview
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Brief Summary
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In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a double low dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.

Official Title
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Comparison of Image Quality Between Double Low Dose Liver CT Using AI-based Iodine Boosting Reconstruction and Standard Contrast-enhanced Liver CT in Patients With Colorectal Cancer: Prospective, Randomized, Non-inferiority Trial

Conditions
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Metastasis to Liver, Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Double low dose CT
* Diagnostic Test: Standard dose CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: colorectal cancer (CRC) patients on surveillance or monitoring for liver metastasis (of CRC) Exclusion Criteria: any relative or absolute contra-indication of CECT diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions

Ages Eligible for Study
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Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose CT<br>Standard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner. | Diagnostic Test: Standard dose CT<br>* CT with standard radiation dose and contrast media dose<br>|
| Experimental: Double low dose CT<br>Double low dose protocol CT using low radiation dose (120 kVp & 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software. | Diagnostic Test: Double low dose CT<br>* Simultaneous reduction of both radiation dose and contrast media dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesion conspicuity on portal venous phase | qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity). Lesion conspicuity is compared between the two arms. | 6 months after primary study completion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesion conspicuity on arterial phase | qualitative analysis of lesion conspicuity on arterial phase on five-point scale (higher score indicates better conspicuity) Lesion conspicuity is compared between the two arms. | 6 months after primary study completion. | 
| lesion detectability | lesion detectability is compared between the two arms, compared with reference standard. Figure-of-merit was obtained. | 12 months after primary study completion. | 
| Radiation dose | Dose-length product (mGy*cm) is compared between the two arms. | 1 month after primary study completion | 
| Contrast media (CM) dose | The amount of CM dose is compared between the two arms. | 1 month after primary study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT