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OpenTrials
Active, Not Recruiting

NCT Number: NCT03151564

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diseases of Liver Colon Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography Scan - 50% Dose Reduction

Diagnostic 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.

Other names: CT scan

Computed Tomography Scan - 70% Dose Reduction

Diagnostic 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.

Other names: CT scan

Deep Learning Image Reconstruction (DLIR)

Diagnostic Test

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

Primary outcomes

  1. Metastasis Detection Accuracy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 12, 2017
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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