Colorectal Cancer MetastaticNCT03038568
Assessing How Normal Variations in CT Scanning Affects Its Interpretation
An observational study of Colorectal Cancer Metastatic, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- CT scan
- How many people
- 169 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2017to 27 Jan 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center, Texas (Data collection only)
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- CT scan
- Keywords
- colorectal liver metastases, CT scan, 17-010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | -15 second time gap between routine abdominal CT and add on CT, Noise Index of 12 Receives: Diagnostic Test: CT scan | |
| Cohort 2 | -15 second time gap between routine abdominal CT and add on CT, Noise Index of 14 Receives: Diagnostic Test: CT scan | |
| Cohort 3 | -15 second time gap between routine abdominal CT and add on CT, Noise Index of 16 Receives: Diagnostic Test: CT scan | |
| Cohort 4 | -10 second time gap between routine abdominal CT and add on CT, Noise index 12 Receives: Diagnostic Test: CT scan | |
| Cohort 5 | -10 second time gap between routine abdominal CT and add on CT, Noise index 14 Receives: Diagnostic Test: CT scan | |
| Cohort 6 | -10 second time gap between routine abdominal CT and add on CT, Noise index 16 Receives: Diagnostic Test: CT scan | |
| Cohort 7 | - 5 second time gap between routine abdominal CT and add on CT, Noise index 12 Receives: Diagnostic Test: CT scan | |
| Cohort 8 | - 5 second time gap between routine abdominal CT and add on CT, Noise index 14 Receives: Diagnostic Test: CT scan | |
| Cohort 9 | - 5 second time gap between routine abdominal CT and add on CT, Noise index 16 Receives: Diagnostic Test: CT scan | |
| Cohort 10 | + 5 second time gap between routine abdominal CT and add on CT, Noise index 12 Receives: Diagnostic Test: CT scan | |
| Cohort 11 | + 5 second time gap between routine abdominal CT and add on CT, Noise index 14 Receives: Diagnostic Test: CT scan | |
| Cohort 12 | + 5 second time gap between routine abdominal CT and add on CT, Noise index 16 Receives: Diagnostic Test: CT scan | |
| Cohort 13 | + 10 second time gap between routine abdominal CT and add on CT, Noise index 12 Receives: Diagnostic Test: CT scan | |
| Cohort 14 | + 10 second time gap between routine abdominal CT and add on CT, Noise index 14 Receives: Diagnostic Test: CT scan | |
| Cohort 15 | + 10 second time gap between routine abdominal CT and add on CT, Noise index 16 Receives: Diagnostic Test: CT scan | |
| Cohort 16 | + 15 second time gap between routine abdominal CT and add on CT, Noise 12 Receives: Diagnostic Test: CT scan | |
| Cohort 17 | + 15 second time gap between routine abdominal CT and add on CT, Noise 14 Receives: Diagnostic Test: CT scan | |
| Cohort 18 | + 15 second time gap between routine abdominal CT and add on CT, Noise 16 Receives: Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start27 Jan 2017
- Primary completion27 Jan 2027 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Sponsor
- Investigators
- Kinh Gian Richard Do, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038568
- Sponsor's protocol ID
- 17-010
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Radiomic Features for Abdominal Tumors on Contrast Enhanced CT
- ClinicalTrials.gov ID
- NCT03038568
- Acronym / sponsor ID
- 17-010
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- colorectal liver metastases, CT scan, 17-010
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 27 Jan 2027 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: CT scan-15 second time gap between routine abdominal CT and add on CT, Noise Index of 12 |
| Cohort 2 | – | Diagnostic Test: CT scan-15 second time gap between routine abdominal CT and add on CT, Noise Index of 14 |
| Cohort 3 | – | Diagnostic Test: CT scan-15 second time gap between routine abdominal CT and add on CT, Noise Index of 16 |
| Cohort 4 | – | Diagnostic Test: CT scan-10 second time gap between routine abdominal CT and add on CT, Noise index 12 |
| Cohort 5 | – | Diagnostic Test: CT scan-10 second time gap between routine abdominal CT and add on CT, Noise index 14 |
| Cohort 6 | – | Diagnostic Test: CT scan-10 second time gap between routine abdominal CT and add on CT, Noise index 16 |
| Cohort 7 | – | Diagnostic Test: CT scan- 5 second time gap between routine abdominal CT and add on CT, Noise index 12 |
| Cohort 8 | – | Diagnostic Test: CT scan- 5 second time gap between routine abdominal CT and add on CT, Noise index 14 |
| Cohort 9 | – | Diagnostic Test: CT scan- 5 second time gap between routine abdominal CT and add on CT, Noise index 16 |
| Cohort 10 | – | Diagnostic Test: CT scan+ 5 second time gap between routine abdominal CT and add on CT, Noise index 12 |
| Cohort 11 | – | Diagnostic Test: CT scan+ 5 second time gap between routine abdominal CT and add on CT, Noise index 14 |
| Cohort 12 | – | Diagnostic Test: CT scan+ 5 second time gap between routine abdominal CT and add on CT, Noise index 16 |
| Cohort 13 | – | Diagnostic Test: CT scan+ 10 second time gap between routine abdominal CT and add on CT, Noise index 12 |
| Cohort 14 | – | Diagnostic Test: CT scan+ 10 second time gap between routine abdominal CT and add on CT, Noise index 14 |
| Cohort 15 | – | Diagnostic Test: CT scan+ 10 second time gap between routine abdominal CT and add on CT, Noise index 16 |
| Cohort 16 | – | Diagnostic Test: CT scan+ 15 second time gap between routine abdominal CT and add on CT, Noise 12 |
| Cohort 17 | – | Diagnostic Test: CT scan+ 15 second time gap between routine abdominal CT and add on CT, Noise 14 |
| Cohort 18 | – | Diagnostic Test: CT scan+ 15 second time gap between routine abdominal CT and add on CT, Noise 16 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CT scanPatients 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. | Diagnostic test | Cohort 1, Cohort 10, Cohort 11, Cohort 12, Cohort 13, Cohort 14, Cohort 15, Cohort 16, Cohort 17, Cohort 18, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
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).
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 22 Apr 2026.
- Memorial Sloan Kettering 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.
Kinh Gian Richard Do, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 3 inclusion and 4 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.