search
Back to results

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

Primary Purpose

Diseases of Liver, Colon Carcinoma, Colorectal Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography Scan - 50% Dose Reduction
Computed Tomography Scan - 70% Dose Reduction
Deep Learning Image Reconstruction (DLIR)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diseases of Liver focused on measuring Diseases of liver, Colon carcinoma, Colorectal carcinoma, Liver metastases, Computed tomography, CT, Reduced radiation doses, Deep Learning Image Reconstructions, DLIR

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Computed Tomography Scan - 50% Dose Reduction

Computed tomography Scan - 70% Dose Reduction

Deep Learning Image Reconstruction (DLIR)

Arm Description

Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2017
Last Updated
September 13, 2023
Sponsor
M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03151564
Brief Title
Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
Official Title
Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diseases of Liver, Colon Carcinoma, Colorectal Carcinoma, Liver Metastases
Keywords
Diseases of liver, Colon carcinoma, Colorectal carcinoma, Liver metastases, Computed tomography, CT, Reduced radiation doses, Deep Learning Image Reconstructions, DLIR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computed Tomography Scan - 50% Dose Reduction
Arm Type
Experimental
Arm Description
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.
Arm Title
Computed tomography Scan - 70% Dose Reduction
Arm Type
Experimental
Arm Description
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.
Arm Title
Deep Learning Image Reconstruction (DLIR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Computed Tomography Scan - 50% Dose Reduction
Other Intervention Name(s)
CT scan
Intervention Description
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.
Intervention Type
Diagnostic Test
Intervention Name(s)
Computed Tomography Scan - 70% Dose Reduction
Other Intervention Name(s)
CT scan
Intervention Description
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.
Intervention Type
Diagnostic Test
Intervention Name(s)
Deep Learning Image Reconstruction (DLIR)
Intervention Description
Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.
Primary Outcome Measure Information:
Title
Metastasis Detection Accuracy
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey T. Jensen, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35014900
Citation
Jensen CT, Gupta S, Saleh MM, Liu X, Wong VK, Salem U, Qiao W, Samei E, Wagner-Bartak NA. Reduced-Dose Deep Learning Reconstruction for Abdominal CT of Liver Metastases. Radiology. 2022 Apr;303(1):90-98. doi: 10.1148/radiol.211838. Epub 2022 Jan 11.
Results Reference
derived
PubMed Identifier
30480489
Citation
Jensen CT, Wagner-Bartak NA, Vu LN, Liu X, Raval B, Martinez D, Wei W, Cheng Y, Samei E, Gupta S. Detection of Colorectal Hepatic Metastases Is Superior at Standard Radiation Dose CT versus Reduced Dose CT. Radiology. 2019 Feb;290(2):400-409. doi: 10.1148/radiol.2018181657. Epub 2018 Nov 27.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs