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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03151564
Collaborator
(none)
140
1
3
73.7
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction
  • Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction
  • Diagnostic Test: Deep Learning Image Reconstruction (DLIR)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
Actual Study Start Date :
May 9, 2017
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03151564
    Other Study ID Numbers:
    • 2016-1135
    • NCI-2018-01272
    First Posted:
    May 12, 2017
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022