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

N/AActive Not RecruitingNCT03151564

M.D. Anderson Cancer Center146 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

146

Conditions

Diseases of Liver Colon Carcinoma Colorectal Carcinoma Liver Metastases

Interventions

Computed Tomography Scan - 50% Dose ReductionDIAGNOSTIC_TEST

Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.

Computed Tomography Scan - 70% Dose ReductionDIAGNOSTIC_TEST

Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.

Deep Learning Image Reconstruction (DLIR)DIAGNOSTIC_TEST

Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient must be \>/= 18 years of age and \</=90 years of age 2. Men and non-pregnant women 3. Pathology proven diagnosis of colon or colorectal carcinoma 4. Liver metastases on most recent CT examination 5. Standard of care CT abdomen examination planned WITH IV contrast Exclusion Criteria: 1. Patients cannot give informed consent 2. Patients cannot undergo CT examination

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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