Assessing How Normal Variations in CT Scanning Affects Its Interpretation

NCT ID: NCT03038568

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-27

Study Completion Date

2026-01-27

Brief Summary

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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

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Conditions

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Colorectal Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

CT scan

Intervention Type DIAGNOSTIC_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 2

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

CT scan

Intervention Type DIAGNOSTIC_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 3

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

CT scan

Intervention Type DIAGNOSTIC_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 4

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

CT scan

Intervention Type DIAGNOSTIC_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 5

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

CT scan

Intervention Type DIAGNOSTIC_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 6

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

CT scan

Intervention Type DIAGNOSTIC_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 7

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

CT scan

Intervention Type DIAGNOSTIC_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 8

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

CT scan

Intervention Type DIAGNOSTIC_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 9

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

CT scan

Intervention Type DIAGNOSTIC_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 10

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

CT scan

Intervention Type DIAGNOSTIC_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 11

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

CT scan

Intervention Type DIAGNOSTIC_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 12

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

CT scan

Intervention Type DIAGNOSTIC_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 13

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

CT scan

Intervention Type DIAGNOSTIC_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 14

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

CT scan

Intervention Type DIAGNOSTIC_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 15

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

CT scan

Intervention Type DIAGNOSTIC_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 16

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

CT scan

Intervention Type DIAGNOSTIC_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 17

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

CT scan

Intervention Type DIAGNOSTIC_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 18

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

CT scan

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kingston Health Sciences Centre

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kinh Gian Richard Do, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

MD Anderson Cancer Center, Texas (Data collection only)

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-010

Identifier Type: -

Identifier Source: org_study_id

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