Assessing How Normal Variations in CT Scanning Affects Its Interpretation

April 17, 2026 updated by: Memorial Sloan Kettering Cancer Center

Stability of Radiomic Features for Abdominal Tumors on Contrast Enhanced CT

The purpose of the study is to see how measurements of tumor differences vary with slight changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even in the setting of variable scan parameters and variable contrast timing. Participants will be consented to undergo an additional CT of their abdomen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kinh Gian Richard Do, MD, PhD
  • Phone Number: 212-639-8591
  • Email: dok@mskcc.org

Study Contact Backup

  • Name: Mithat Gonen, PhD
  • Phone Number: 646-888-8238

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center, Texas (Data collection only)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who undergo contrast enhanced CT scanning for colorectal liver metastases will be consented for one additional CT abdomen phase during the same imaging session.

Description

Inclusion Criteria:

  • Patients ≥ 18 years of age on the day of signed informed consent
  • Patients scheduled and approved for contrast enhanced CT that includes imaging of the abdomen and pelvis following the Department of Radiology standard of care protocol as per local institutional guidelines
  • Patients with measurable colorectal liver metastases on prior imaging, with at least one tumor greater than 2.0 cm in axial maximal diameter

Exclusion Criteria:

  • Patient who is pregnant and/or lactating
  • Patient scheduled for CT that includes the abdomen with a multiphasic contrast enhanced protocol (e.g. Triple Phase or Quadruple Phase Liver CT)
  • Patient who require reduced intravenous contrast dose based on the Department of Radiology contrast policy as per local institutional guidelines
  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
-15 second time gap between routine abdominal CT and add on CT, Noise Index of 12
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 2
-15 second time gap between routine abdominal CT and add on CT, Noise Index of 14
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 3
-15 second time gap between routine abdominal CT and add on CT, Noise Index of 16
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 4
-10 second time gap between routine abdominal CT and add on CT, Noise index 12
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 5
-10 second time gap between routine abdominal CT and add on CT, Noise index 14
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 6
-10 second time gap between routine abdominal CT and add on CT, Noise index 16
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 7
- 5 second time gap between routine abdominal CT and add on CT, Noise index 12
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 8
- 5 second time gap between routine abdominal CT and add on CT, Noise index 14
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 9
- 5 second time gap between routine abdominal CT and add on CT, Noise index 16
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 10
+ 5 second time gap between routine abdominal CT and add on CT, Noise index 12
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 11
+ 5 second time gap between routine abdominal CT and add on CT, Noise index 14
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 12
+ 5 second time gap between routine abdominal CT and add on CT, Noise index 16
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 13
+ 10 second time gap between routine abdominal CT and add on CT, Noise index 12
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 14
+ 10 second time gap between routine abdominal CT and add on CT, Noise index 14
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 15
+ 10 second time gap between routine abdominal CT and add on CT, Noise index 16
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 16
+ 15 second time gap between routine abdominal CT and add on CT, Noise 12
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 17
+ 15 second time gap between routine abdominal CT and add on CT, Noise 14
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
Cohort 18
+ 15 second time gap between routine abdominal CT and add on CT, Noise 16
Diagnostic test: CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans
Time Frame: 2 years
There will be 18 cohorts, each cohort differing by the length of the time gap in acquisition and noise index. In addition each acquisition will be reconstructed in 21 different ways (combinations of 3 slice thicknesses and 7 ASiR levels).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Queen's University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kinh Gian Richard Do, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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