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
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Condition or disease | Intervention/treatment |
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Colo-rectal Cancer | Other: CT Images |
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 |
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 |
Group/Cohort | Intervention/treatment |
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Patients with Colo-rectal Cancer
Patients with Colo-rectal Cancer will be included.
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Other: CT Images
Analysis of CT images of peritoneal and/or liver metastases from colorectal cancer |
- 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).
- 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).
- Evaluation of response to chemotherapy in RECIST 1.1 [ Time Frame: Year : 1 ]Collection of demographic, biological and surgical data.
- Evaluation of response to chemotherapy in Radiomics [ Time Frame: Year : 1 ]Collection of demographic, biological and surgical data.
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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 |
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)
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
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 |
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 |
Principal Investigator: | Rémi GRANGE, MD | CHU Saint Etienne |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colo-rectal cancer spectral CT scan liver metastases peritoneal carcinosis |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |