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

Colo-rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024837
• Other study ID #: IRBN1162022/CHUSTE
• Status: Recruiting
• Start date: June 7, 2023
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Rémi GRANGE, MD
• Phone: (0)477828963
• Email: remi.grange[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• CT Images
Analysis of CT images of peritoneal and/or liver metastases from colorectal cancer

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Evaluation of response to chemotherapy in RECIST 1.1	Collection of demographic, biological and surgical data.	Year : 1
Secondary	Evaluation of response to chemotherapy in Radiomics	Collection of demographic, biological and surgical data.	Year : 1