Colon Carcinoma, Colorectal Carcinoma, Diseases of Liver, Liver Metastases
Conditions
Keywords
Diseases of liver, Colon carcinoma, Colorectal carcinoma, Liver metastases, Computed tomography, CT, Reduced radiation doses, Deep Learning Image Reconstructions, DLIR
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTComputed Tomography Scan - 50% Dose Reduction
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_TESTComputed Tomography Scan - 70% Dose Reduction
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_TESTDeep Learning Image Reconstruction (DLIR)
Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis Detection Accuracy | 1 day | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCorey T. Jensen, MD
M.D. Anderson Cancer Center
Outcome results
None listed