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

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ClinicalTrials.gov Identifier: NCT06024837
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Colo-rectal Cancer 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study
Actual Study Start Date : June 7, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of peritoneal lesion mapping between spectral scanning and conventional scanning [ Time Frame: Year : 1 ]
    Comparison of peritoneal lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).

  2. Comparison of hepatic lesion mapping between spectral scanning and conventional scanning [ Time Frame: Year : 1 ]
    Comparison of hepatic lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).


Secondary Outcome Measures :
  1. Evaluation of response to chemotherapy in RECIST 1.1 [ Time Frame: Year : 1 ]
    Collection of demographic, biological and surgical data.

  2. Evaluation of response to chemotherapy in Radiomics [ Time Frame: Year : 1 ]
    Collection of demographic, biological and surgical data.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024837


Contacts
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Contact: Rémi GRANGE, MD (0)477828963 ext +33 remi.grange@chu-st-etienne.fr
Contact: Sylvain GRANGE, MD (0)477829066 ext +33 sylvain.grange@chu-st-etienne.fr

Locations
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France
CHU Saint-Etienne Recruiting
Saint-Étienne, France, 42000
Contact: Rémi GRANGE, MD    (0)477828963 ext +33    remi.grange@chu-st-etienne.fr   
Contact: Sylvain GRANGE, MD    (0)477829066 ext +33    sylvain.grange@chu-st-etienne.fr   
Principal Investigator: Rémi Grange, MD         
Sub-Investigator: Sylvain Grange, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Rémi GRANGE, MD CHU Saint Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT06024837    
Other Study ID Numbers: IRBN1162022/CHUSTE
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Colo-rectal cancer
spectral CT scan
liver metastases
peritoneal carcinosis
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases