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

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: Colorectal Adenocarcinoma
• Intervention / Treatment: Other: No supplementary intervention is performed

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

Study Locations

• Switzerland
  • Fribourg, Switzerland, 1708
    • Recruiting
    • Sonaz Malekzadeh
    • Contact: Sonaz Malekzadeh, MD; Phone Number: +41783012848; Email: soonazmalakzadeh@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	Difference of iodine uptake between colorectal tumor and pseudo-thickened colorectal wall on DECT	3.11.2021

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois

Study record dates

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: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• 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