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NCT03151564 Clinical Trial

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

Liver Metastases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03151564
Other study ID # 2016-1135
Secondary ID NCI-2018-01272
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 9, 2017
Est. completion date April 30, 2025

Study information
Verified date March 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 146
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Computed 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.
• Computed 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.
• Deep Learning Image Reconstruction (DLIR)
Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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