The Role of Quantitative Measures on Dual-energy CT in the Prediction of Colorectal Adenocarcinoma

August 2, 2022 updated by: Malekzadeh, Hôpital Fribourgeois
To demonstrate the potential role of dual-energy computed tomography (DECT) by iodine maps data, aimed at discriminating colon cancer from colon wall pseudo-thickening.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospectively, 50 consecutive patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging in the Department of Radiology at our institution from April 2020, will be included. The exclusion criteria are as follows: patients with body mass index (BMI) above 30 kg/m2, patients with renal insufficiency (estimated glomerular filtration rate < 30 ml/min), allergy to iodinated contrast and a known history of previous abdominal radiotherapy.

All patients will undergo a staging enhanced thoraco-abdominal CT by 256-slices CTs (Revolution CT, GE healthcare) at Fribourg hospital. DECTs will be acquired without an enema, rectal insufflation or oral contrast to have collapsed colorectal wall for further measurements and to simulate routine clinical practice. No additional screening procedures, such as a laboratory or diagnostic tests are necessary for the present study.

Upon acquiring 50 patients, CT quantitative assessments will be performed. Initially, data will be transferred to AW Advantage workstations (GE Healthcare). Thereafter, for each patient, the iodine map images will be created by post-processing by. All CT quantitative measurements will be performed independently by two radiologists. Three regions of interest (ROI) will be applied to colorectal tumor and the normal collapsed colorectal wall (confirmed previously by colonoscopy) and consequently, the mean of these measurements will be reported. These measurements correspond to mean iodine uptake of colorectal tumor and normal collapsed wall, respectively. Finally, the iodine uptake of the tumoral lesion and normal collapsed wall in each patient will be compared to demonstrate the significant difference in iodine uptake. Investigators anticipate that the obtained cut-off value will be a new benchmark in clinical practice, to exclude the colorectal tumors on non-prepared collapsed colon wall and eliminate the need for a complementary colonoscopy.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Locations

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

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging in the Department of Radiology at our institution from April 2020

Description

Inclusion Criteria:

. pathology-proved colorectal tumor

Exclusion Criteria:

  • BMI above 30 kg/m2
  • renal insufficiency (estimated glomerular filtration rate < 30 ml/min),
  • allergy to iodinated contrast, and a
  • known history of previous abdominal radiotherapy

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal adenocarcinoma
patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging
Other: No supplementary intervention is performed
No supplementary intervention will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of iodine uptake
Time Frame: 3.11.2021
Difference of iodine uptake between colorectal tumor and pseudo-thickened colorectal wall on DECT
3.11.2021

Collaborators and Investigators

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

Sponsor

Hôpital Fribourgeois

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)

April 1, 2020

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Subscribe