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Assessing How Normal Variations in CT Scanning Affects Its Interpretation

Active, not recruiting
Conditions
Colorectal Cancer Metastatic
Interventions
Diagnostic Test: CT scan
Registration Number
NCT03038568
Lead Sponsor
Memorial Sloan Kettering Cancer Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
169
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cohort 8CT scan- 5 second time gap between routine abdominal CT and add on CT, Noise index 14
Cohort 2CT scan-15 second time gap between routine abdominal CT and add on CT, Noise Index of 14
Cohort 9CT scan- 5 second time gap between routine abdominal CT and add on CT, Noise index 16
Cohort 10CT scan+ 5 second time gap between routine abdominal CT and add on CT, Noise index 12
Cohort 1CT scan-15 second time gap between routine abdominal CT and add on CT, Noise Index of 12
Cohort 3CT scan-15 second time gap between routine abdominal CT and add on CT, Noise Index of 16
Cohort 4CT scan-10 second time gap between routine abdominal CT and add on CT, Noise index 12
Cohort 11CT scan+ 5 second time gap between routine abdominal CT and add on CT, Noise index 14
Cohort 7CT scan- 5 second time gap between routine abdominal CT and add on CT, Noise index 12
Cohort 12CT scan+ 5 second time gap between routine abdominal CT and add on CT, Noise index 16
Cohort 14CT scan+ 10 second time gap between routine abdominal CT and add on CT, Noise index 14
Cohort 5CT scan-10 second time gap between routine abdominal CT and add on CT, Noise index 14
Cohort 6CT scan-10 second time gap between routine abdominal CT and add on CT, Noise index 16
Cohort 17CT scan+ 15 second time gap between routine abdominal CT and add on CT, Noise 14
Cohort 18CT scan+ 15 second time gap between routine abdominal CT and add on CT, Noise 16
Cohort 13CT scan+ 10 second time gap between routine abdominal CT and add on CT, Noise index 12
Cohort 15CT scan+ 10 second time gap between routine abdominal CT and add on CT, Noise index 16
Cohort 16CT scan+ 15 second time gap between routine abdominal CT and add on CT, Noise 12
Primary Outcome Measures
NameTimeMethod
assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans2 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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

MD Anderson Cancer Center, Texas (Data collection only)

🇺🇸

Houston, Texas, United States

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