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

NCT ID: NCT03151564

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Diseases of Liver Colon Carcinoma Colorectal Carcinoma Liver Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography Scan - 50% Dose Reduction

Intervention Type DIAGNOSTIC_TEST

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.

Group Type EXPERIMENTAL

Computed Tomography Scan - 70% Dose Reduction

Intervention Type DIAGNOSTIC_TEST

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)

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.

Group Type EXPERIMENTAL

Deep Learning Image Reconstruction (DLIR)

Intervention Type DIAGNOSTIC_TEST

Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Deep Learning Image Reconstruction (DLIR)

Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CT scan CT scan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corey T. Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35014900 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30480489 (View on PubMed)

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2018-01272

Identifier Type: OTHER

Identifier Source: secondary_id

2016-1135

Identifier Type: -

Identifier Source: org_study_id

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