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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Colorectal Carcinoma; Colon Carcinoma; Diseases of Liver; Liver Metastases

Treatments: Diagnostic Test: Deep Learning Image Reconstruction (DLIR); Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction; Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03151564

NCI-2018-01272 (Other Identifier)

2016-1135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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146 participants in 3 patient groups

Computed Tomography Scan - 50% Dose Reduction

Experimental group

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.

Treatment:

Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction

Computed tomography Scan - 70% Dose Reduction

Experimental group

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.

Treatment:

Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction

Deep Learning Image Reconstruction (DLIR)

Experimental group

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.

Treatment:

Diagnostic Test: Deep Learning Image Reconstruction (DLIR)