Clinical trial NCT03151564: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metastasis Detection Accuracy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Corey T. Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.