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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Colon Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Diseases of Liver
• Liver Diseases
• Liver Metastases
• Neoplasm Metastasis

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

External Links

•   MD Anderson Cancer Center