Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study

Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose and irradiation compared to conventional scanning. It uses the difference in attenuation of the material according to the two different energy levels of the incident x-ray beams. The dual-energy scanner has a wide range of clinical applications, particularly in abdominal imaging.

Study Overview

• Status: Recruiting
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Other: CT Images

Detailed Description

First of all, the virtual creation of mono-energy images between 40 and 140 keV has shown subjective and objective improvement of tumor detection of hypovascular lesions using low energies (40keV). It has been shown to be of interest in vascular and cardiac imaging, and to reduce artefacts in bone imaging. However, its performance in oncology analysis has been little studied. The selection of patients for peritoneal and hepatic carcinosis surgery is fundamental, as surgery allows a prolongation of survival, but are associated with a non-negligible morbi-mortality rate.

Spectral CT provides improved detection of peritoneal carcinosis and liver metastases of colorectal cancer compared to conventional CT acquisition.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sylvain GRANGE, MD; Phone Number: +33 (0)477829066; Email: Sylvain.Grange@chu-st-etienne.fr
• Study Contact Backup: Name: Rémi GRANGE, MD; Phone Number: +33 (0)477828963; Email: remi.grange@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42000
    • Recruiting
    • CHU Saint-Etienne
    • Contact: Sylvain GRANGE, MD; Phone Number: +33 (0)477829066; Email: Sylvain.Grange@chu-st-etienne.fr
    • Sub-Investigator: Sylvain Grange, MD
    • Contact: Rémi GRANGE, MD; Phone Number: +33 (0)477828963; Email: remi.grange@chu-st-etienne.fr
    • Principal Investigator: Rémi Grange, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with synchronous or metachronous peritoneal and/or liver metastases of colorectal cancer with curative surgical plans.

Description

Inclusion Criteria:

• Patients followed for colorectal cancer with synchronous or metachronous liver metastases and/or peritoneal carcinosis
• Patients with a curative surgical resection plan

Exclusion Criteria:

• Patients with non-metastatic colorectal cancer
• Patients treated with chemotherapy without surgical plans
• Patients with colorectal cancer with extra-hepatic and extra-peritoneal metastases alone (e.g. lung, bone)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Colo-rectal Cancer; Patients with Colo-rectal Cancer will be included.	Other: CT Images; Analysis of CT images of peritoneal and/or liver metastases from colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of peritoneal lesion mapping between spectral scanning and conventional scanning	Comparison of peritoneal lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).	Year : 1
Comparison of hepatic lesion mapping between spectral scanning and conventional scanning	Comparison of hepatic lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).	Year : 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of response to chemotherapy in RECIST 1.1	Collection of demographic, biological and surgical data.	Year : 1
Evaluation of response to chemotherapy in Radiomics	Collection of demographic, biological and surgical data.	Year : 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Rémi GRANGE, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: liver metastases; peritoneal carcinosis; Colo-rectal cancer; spectral CT scan
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: IRBN1162022/CHUSTE

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