NCT03038568

Brief 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 and variable contrast timing. Participants will be consented to undergo an additional CT of their abdomen.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2017Jan 2027

Study Start

First participant enrolled

January 27, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

January 30, 2017

Last Update Submit

April 17, 2026

Conditions

Keywords

colorectal liver metastasesCT scan17-010

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 years

Study Arms (18)

Cohort 1

-15 second time gap between routine abdominal CT and add on CT, Noise Index of 12

Diagnostic Test: CT scan

Cohort 2

-15 second time gap between routine abdominal CT and add on CT, Noise Index of 14

Diagnostic Test: CT scan

Cohort 3

-15 second time gap between routine abdominal CT and add on CT, Noise Index of 16

Diagnostic Test: CT scan

Cohort 4

-10 second time gap between routine abdominal CT and add on CT, Noise index 12

Diagnostic Test: CT scan

Cohort 5

-10 second time gap between routine abdominal CT and add on CT, Noise index 14

Diagnostic Test: CT scan

Cohort 6

-10 second time gap between routine abdominal CT and add on CT, Noise index 16

Diagnostic Test: CT scan

Cohort 7

\- 5 second time gap between routine abdominal CT and add on CT, Noise index 12

Diagnostic Test: CT scan

Cohort 8

\- 5 second time gap between routine abdominal CT and add on CT, Noise index 14

Diagnostic Test: CT scan

Cohort 9

\- 5 second time gap between routine abdominal CT and add on CT, Noise index 16

Diagnostic Test: CT scan

Cohort 10

\+ 5 second time gap between routine abdominal CT and add on CT, Noise index 12

Diagnostic Test: CT scan

Cohort 11

\+ 5 second time gap between routine abdominal CT and add on CT, Noise index 14

Diagnostic Test: CT scan

Cohort 12

\+ 5 second time gap between routine abdominal CT and add on CT, Noise index 16

Diagnostic Test: CT scan

Cohort 13

\+ 10 second time gap between routine abdominal CT and add on CT, Noise index 12

Diagnostic Test: CT scan

Cohort 14

\+ 10 second time gap between routine abdominal CT and add on CT, Noise index 14

Diagnostic Test: CT scan

Cohort 15

\+ 10 second time gap between routine abdominal CT and add on CT, Noise index 16

Diagnostic Test: CT scan

Cohort 16

\+ 15 second time gap between routine abdominal CT and add on CT, Noise 12

Diagnostic Test: CT scan

Cohort 17

\+ 15 second time gap between routine abdominal CT and add on CT, Noise 14

Diagnostic Test: CT scan

Cohort 18

\+ 15 second time gap between routine abdominal CT and add on CT, Noise 16

Diagnostic Test: CT scan

Interventions

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.

Cohort 1Cohort 10Cohort 11Cohort 12Cohort 13Cohort 14Cohort 15Cohort 16Cohort 17Cohort 18Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center, Texas (Data collection only)

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Kinh Gian Richard Do, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

January 31, 2017

Study Start

January 27, 2017

Primary Completion (Estimated)

January 27, 2027

Study Completion (Estimated)

January 27, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations