Diseases of LiverNCT03151564
Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
A study testing Computed Tomography Scan - 50% Dose Reduction, Computed Tomography Scan - 70% Dose Reduction and Deep Learning Image Reconstruction (DLIR) in people with Diseases of Liver and Colon Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diseases of Liver, Colon Carcinoma, Colorectal Carcinoma
- What is being tested?
- Computed Tomography Scan - 50% Dose Reduction, Computed Tomography Scan - 70% Dose Reduction and Deep Learning Image Reconstruction (DLIR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients cannot give informed consent
- Patients cannot undergo CT examination
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Being tested
- Computed Tomography Scan - 50% Dose Reduction, Computed Tomography Scan - 70% Dose Reduction, Deep Learning Image Reconstruction (DLIR)
- Keywords
- Diseases of liver, Colon carcinoma, Colorectal carcinoma, Liver metastases, Computed tomography, CT, Reduced radiation doses, Deep Learning Image Reconstructions, DLIR
- Medical subject headings
- Digestive System Diseases, Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography Scan - 50% Dose ReductionDiagnostic test
Also called CT scan
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 ReductionDiagnostic test
Also called CT scan
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)Diagnostic test
Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique.
| Study group | Role | What they receive |
|---|---|---|
| Computed Tomography Scan - 50% Dose Reduction | Experimental | Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction. Receives: Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction |
| Computed tomography Scan - 70% Dose Reduction | Experimental | Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction. Receives: Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction |
| Deep Learning Image Reconstruction (DLIR) | Experimental | 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. Receives: Diagnostic Test: Deep Learning Image Reconstruction (DLIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start9 May 2017
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diseases of LiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corey T. Jensen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151564
- Sponsor's protocol ID
- 2016-1135
- Other IDs
- NCI-2018-01272
- Status last verified
- Sep 2026
- First submitted
- 9 May 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35014900Jensen 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.
PubMed 30480489
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
- ClinicalTrials.gov ID
- NCT03151564
- Acronym / sponsor ID
- 2016-1135
- Keywords
- Diseases of liver, Colon carcinoma, Colorectal carcinoma, Liver metastases, Computed tomography, CT, Reduced radiation doses, Deep Learning Image Reconstructions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computed Tomography Scan - 50% Dose Reduction | Experimental | Diagnostic Test: Computed Tomography Scan - 50% Dose ReductionParticipants 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 | Experimental | Diagnostic Test: Computed Tomography Scan - 70% Dose ReductionParticipants 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) | Experimental | Diagnostic Test: 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients cannot give informed consent
- Patients cannot undergo CT examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography Scan - 50% Dose ReductionAlso: CT scanParticipants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction. | Diagnostic test | Computed Tomography Scan - 50% Dose Reduction |
| Computed Tomography Scan - 70% Dose ReductionAlso: CT scanParticipants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction. | Diagnostic test | Computed tomography Scan - 70% Dose Reduction |
| Deep Learning Image Reconstruction (DLIR)Participants to receive standard-of-care imaging without the artificial intelligence software and imaging technique. | Diagnostic test | Deep Learning Image Reconstruction (DLIR) |
Primary outcome
Metastasis Detection Accuracy
Time frame: 1 day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 35014900Jensen 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.
- Derived from this study: PubMed 30480489Jensen 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey T. Jensen, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography Scan - 50% Dose Reduction, Computed Tomography Scan - 70% Dose Reduction and Deep Learning Image Reconstruction (DLIR) in people with Diseases of Liver and Colon Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis Detection Accuracy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151564, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.