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

March 3, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • CT scan
Experimental: 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.
Diagnostic test: 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.
Other Names:
  • CT scan
Experimental: Deep Learning Image Reconstruction (DLIR)
DLIR is available in both single (SE) and dual/multi energy (DE) CT scanning modes. DLIR SECT and DLIR DECT reconstructions have yet to be compared.
Diagnostic test: Deep Learning Image Reconstruction (DLIR)
Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Corey T. Jensen, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1135
  • NCI-2018-01272 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Metastases

Clinical Trials on Computed Tomography Scan - 50% Dose Reduction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe